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The Clinical Trial Associate (CTA) provides essential operational and administrative support to clinical trial teams to ensure the effective planning, execution, and close-out of clinical studies. The role supports Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and project teams in maintaining trial documentation, tracking study progress, and ensuring compliance with ICH-GCP, SOPs, and regulatory requirements. Key Responsibilities Trial Management Support • Support study start-up, conduct, and close-out activities across assigned clinical trials, • Assist CRAs and CTMs with day-to-day trial operations and coordination, • Track study milestones, deliverables, and timelines Documentation & TMF Management • Maintain the Trial Master File (TMF) ensuring completeness, accuracy, and inspection readiness, • Collect, review, file, and archive essential study documents, • Support TMF quality checks and reconciliation activities Site & Vendor Coordination • Support site initiation, monitoring, and close-out activities, • Track site documents including CVs, training records, regulatory approvals, and essential correspondence, • Coordinate logistics for investigator meetings, monitoring visits, and study materials Regulatory & Compliance Support • Assist with regulatory submissions and maintenance of regulatory files, • Ensure documentation complies with ICH-GCP, SOPs, and applicable regulations, • Support audit and inspection readiness activities Data & System Management • Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.), • Support data entry and reconciliation across clinical systems Required Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field, • 1–3 years of experience in clinical research or clinical trial operations, • Basic understanding of clinical trial processes and ICH-GCP guidelines, • Experience working with eTMF and CTMS systems, • Strong organizational and documentation skills, • Excellent written and verbal communication abilities Preferred Qualifications • Experience in CRO or FSP environment, • Exposure to global clinical trials, • Experience supporting Phase I–IV clinical studies, • Familiarity with sponsor-specific SOPs and processes Key Competencies • Attention to detail and quality focus, • Strong coordination and follow-up skills, • Ability to manage multiple tasks and timelines, • Collaborative team player, • Proficiency in MS Office (Excel, Word, PowerPoint) Work Environment • Office-based / hybrid / remote (as applicable), • May require occasional travel for investigator meetings or training

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants. Company: One of Our Clients Job Description: Job Title: Associate Director Medical Publications Location: 50% onsite at Giralda Farms, Madison, NJ Duration: 12+ Months (Extendable) Pay Rate: $75.00 - 77.58/hr on W2 Top Requirements: • 5-10 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications; experience in both local country & global preferred, • Advance scientific degree, PharmD, PhD or MD preferred, • Working knowledge of Microsoft suite of applications, and familiar with publication management (iEnvision) and content management (Veeva) tools, • Ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills Purpose and Scope of the Position: • Work with Medical Communication Director and the publications matrix team to help with development of publications and/or medical content within assigned therapeutic area Required Competencies: Knowledge, Skills, and Abilities: • Advance scientific degree, PharmD, PhD or MD preferred, • 5-10 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications; experience in both local country & global preferred, • Proven ability to work in an ambiguous environment with a focus on deliverables, • Ability to analyze and interpret trial data, • Ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills, • Ability to influence and negotiate appropriate solutions Duties and Responsibilities: • Take on assigned projects to help with development and execution of functionally integrated and aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape, • Serve as a subject matter expert to internal audiences related to communication landscape, HCP preferences, publication and scientific content planning, data disclosure / dissemination., • Ensure publication & scientific content standards are aligned with Good Publication Practices and industry standards to ensure the highest degree of integrity, quality and transparency Education and Experience: • Pharmaceutical/Healthcare Industry, • External compliance, transparency and conflict-of-interest regulated work environments, • In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication, • Certified Medical Publication Professional (CMPP), and ISMPP active member highly desired, • Understanding of clinical trial design and execution, statistical methods and clinical trial data reporting requirements, • Working knowledge of Microsoft suite of applications, and familiar with publication management (iEnvision) and content management (Veeva) tools Working Conditions: Office/desk work in an open space environment Awards and Accolades: America's Most Honored Businesses (Top 10%) Awarded by USPAAC for the Fastest Growing Business in the US 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020) Fastest 50 by NJ Biz (2020, 2019, 2020) INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list) Top 100 by Dallas Business Journal (2020 and 2019) Proven Supplier of the Year by Workforce Logiq (2020 and 2019) 2019 Spirit of Alliance Award by Agile1 2018 Best of the Best Platinum Award by Agile1 2018 TechServe Alliance Excellence Awards Winner 2017 Best of the Best Gold Award by Agile1(Act1 Group)

Hackensack University Medical Center: Nationally Recognized in Neurosciences Cognitive/Behavioral Neurologist Physician The Center for Memory Loss & Brain Health at the Department of Neurology at Hackensack University Medical Center (HUMC), a major academic medical center within the Hackensack Meridian Health system, seeks to employ a full time BE/BC Cognitive / Behavioral Neurologist. The successful candidate will have completed a residency in Neurology and a UCNS accredited fellowship in Behavioral Neurology & Neuropsychiatry. Role at the Dementia Center and faculty rank at Hackensack Meridian School of Medicine are commensurate with experience. The clinical focus is on patients at risk for dementia, mild cognitive impairment, and dementia. The Center seeks candidates with interest in outcomes research, translational research, clinical trials, and teaching of medical & graduate students & residents. The Center espouses an interprofessional approach in which geriatricians, neurologists, psychiatrists, neuro- & health psychologists, social workers & rehab therapists who are cognizant of health care disparities provide patient -centered care, accurate diagnoses, state-of- the-art treatment, opportunities for clinical trial participation, and to maximize community living & prevent caregiver burn-out. We are a site in the CMS GUIDE program, an alternate payment model to provide comprehensive dementia care to patients and caregivers living in the community and help improve outcomes like ED visits, hospitalizations and long term placement. This position will be jointly recruited by Florian P. Thomas, MD, PhD, Professor & Chair of the Neuroscience Institute & Department of Neurology at HUMC & the School of Medicine, & Manisha Parulekar, MD, Director, Division of Geriatrics at HUMC & Associate Professor of Internal Medicine at the School. For 2025-2026 HUMC is ranked #1 Adult & Children’s Hospital in NJ & NY Metro Area by US News & World Report. It is one of 5 major academic medical centers in the nation to receive Healthgrades America’s 50 Best Hospitals’ Award for 5 consecutive years. HUMC consistently achieves Magnet recognition for nursing excellence. Hackensack Meridian Health is the largest, most comprehensive & integrated network in NJ with more than 500 patient care & physician practices throughout NJ. It includes 17 hospitals from Bergen to Ocean counties & 3 academic medical centers, has >35,000 team members & >7,000 physicians. Neurosciences at HUMC: • Has been recognized among the Top 50 Adult Neurology & Neurosurgery programs in U.S. News & World Report since 2021 HMH is committed to pay equity and transparency for our team members. The minimum base salary for this position is $258,056. The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting base salary is provided for informational purposes only and is not a guarantee of a specific offer. The base compensation determined at the time of the offer may be different than the posted base salary based on a number of non-discriminatory factors, including but not limited to: Specialization: Area of specialization and sub-specialization. Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant experience in the areas of specialization and sub-specialization. Leadership: Relevant experience as a department chair or chief, practice group leader, or other leadership roles. Education and Certifications: Degrees attained, residencies, fellowships, board certifications, research, and publications. Productivity: Levels of productivity, quality and patient satisfaction. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the specialty and/or sub-specialty. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, tuition reimbursement, and retirement benefits. The final compensation and benefits package will be discussed during the interview process. HOW TO APPLY: For immediate consideration please contact: Nancy Massa Physician Recruiter Email: Phone: 732-890-9339

The Center for Multiple Sclerosis (MS) and Related Diseases in the Department of Neurology at Hackensack University Medical Center (HUMC), a major academic medical center within the Hackensack Meridian Health( HMH) system, seeks to employ a full-time BC/BE neurologist with fellowship training in MS, neuromyelitis optica & related disorders & interest in teaching neurology and other residents and medical students. The Center boasts a robust clinical trial program with Phase 1b, 2, 3, and 4b studies, including CAR-T studies and integrated digital solutions. The Center seeks candidates with an interest in outcomes research, clinical trials & translational research. The Center fosters an interprofessional approach in which neurologists, psychologists, neurorehabilitation specialists, pain management physicians, neuro-ophthalmologists & social workers who are cognizant of health care disparities, strive to provide patient-centered care, accurate diagnoses, state-of-the-art treatment, opportunities for clinical trial participation & to maximize community living. Faculty rank at Hackensack Meridian School of Medicine will be commensurate with experience. This position will be recruited by Krupa Pandey, MD, Director, Division of Multiple Sclerosis & Vice-Chair of Research for the Department of Neurology & Associate Professor of Neurology at the School of Medicine, and Florian P. Thomas, MD, PhD, Professor & Chair of the Neuroscience Institute & the Department of Neurology at HUMC & the School of Medicine. The Center is a nationally recognized leader in MScare. It is accredited as a Center for Comprehensive MS Care by the National MS Society and is a member of the Consortium of Multiple Sclerosis Centers. The Center is led by Dr. Krupa Pandey, a fellowship-trained MS specialist, features 2 other MS specialists, an APN, and 2 registered nurses. The Center has over 1250 established MS patients and is rapidly growing. HMH is the largest, most comprehensive, and integrated network in New Jersey, with 18 hospitals and more than 500 patient care and physician practice locations throughout the state. It comprises three academic medical centers (all featuring Comprehensive Stroke Centers), and has a dedicated team of over 36,000 members and 7,000 physicians. HUMC is consistently recognized for its excellence: For 2025-2026, U.S. News & World Report ranked HUMC as the #1 hospital in New Jersey and the New York metro area, with Neurosurgery-Neurology being in the top 50 since 2021. HUMC is the first hospital in New Jersey and only the second in the nation to achieve Magnet recognition for nursing excellence seven consecutive times. HUMC has also been distinguished as one of Healthgrades' "America's 50 Best Hospitals. It is located 8 miles west of Northern Manhattan. The successful candidate will possess the following qualifications: • Excellent clinical skills, • Fellowship trained in Neuroimmunology, • Board Eligible in Neurology, • Ability to obtain professional licensure, DEA and CDS licenses in New Jersey, • Track record of teaching medical students and residents, • Track record of scholarship, • Has 100+ Team Members. Prominent specialties include Epilepsy, MS, Stroke, Neurosurgery, Neuro-Oncology, Movement Disorders, Neuro-Ophthalmology, Neurogenetics, Neurocritical Care, Sleep Medicine, Hereditary Neuropathy, Headache/Pain Medicine, TBI/Concussion & ALS, • Active Clinical Research Unit led by physician-director with several coordinators & multiple ongoing sponsored & investigator-initiated research projects in MS, Stroke, Spinal Cord Injury, Hereditary Neuropathy, Pain, ALS, Dementia & Movement Disorders HOW TO APPLY: Nancy Massa Physician Recruiter Email: Phone: 732-890-9339 HMH is committed to pay equity and transparency for our team members. The minimum base salary for this position is $228,730.. The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting base salary is provided for informational purposes only and is not a guarantee of a specific offer. The base compensation determined at the time of the offer may be different than the posted base salary based on a number of non-discriminatory factors, including but not limited to: Specialization: Area of specialization and sub-specialization. Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. Experience: Years of relevant experience in the areas of specialization and sub-specialization. Leadership: Relevant experience as a department chair or chief, practice group leader, or other leadership roles. Education and Certifications: Degrees attained, residencies, fellowships, board certifications, research, and publications. Productivity: Levels of productivity, quality, and patient satisfaction. Skills: Demonstrated proficiency in relevant skills and competencies. Geographic Location: Cost of living and market rates for the specific location. Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the specialty and/or sub-specialty. Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, tuition reimbursement, and retirement benefits. The final compensation and benefits package will be discussed during the interview process.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Provide expert opinion on CMC topics planned or performed, • Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards, • Assist with the development of global CMC regulatory strategies, • Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Assist with the design of CMC protocols, • Collaborate with other groups when needed to address CMC related matters, • Prepare responses to Health Authority comments and questions pertaining to CMC issues, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance, • Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience in the management and preparation of the submission of CMC modules in eCTD format required, • Experience with organizing responses to Health Authority requests required, • Experience with regulatory submissions outside of the US preferred, • Experience managing staff preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority CMC guidance documents and requirements, • Good leadership skills with the ability to direct and develop professional staff, • Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines, • Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred, • Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities, • Excellent organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • This position will work closely with scientific colleagues throughout the day, often on a project team basis., • This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $200,000 (entry-level qualifications) to $220,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: Reporting directly to the Associate Director of Regulatory Science (the "Associate Director") of the Clinical Trials Office (the "CTO") of Columbia University's Vagelos College of Physicians & Surgeons ("P&S") at Columbia University Irving Medical Center ("CUIMC"), the Regulatory Science Specialist assists the Associate Director in overseeing the CTO's regulatory compliance and providing assistance to the research community in the development and conduct of clinical trials. The CTO, which is operated jointly with the New York-Presbyterian Hospital ("NYPH") assists investigators and academic/research staff in developing clinical trials at CUIMC and provides administrative resources and infrastructure to build and sustain clinical trials research. Responsibilities The Regulatory Science Specialist is responsible for the following: • Collaborates with the Associate Director, the Executive Director of the CTO (the "Director"), the Medical Director of the CTO, CUIMC faculty and administration and NYPH administration in meeting the institutional needs regarding clinical trial compliance, quality assurance, training and process-improvement goals., • Assists the Associate Director in developing and implementing policies and procedures designed to assure that clinical trials are carried out in compliance with applicable federal and state regulations, including those promulgated in the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services and the rules of the Joint Commission., • Assists the Medical Director and Associate Director of Regulatory Science in implementing the IND/IDE Assistance Program, which provides regulatory guidance in connection with investigator initiated clinical trials., • Assists in the implementation of a training program for research personnel, including research newsletters, workshops, and didactic training sessions upon request., • Provides guidance regarding regulatory and institutional requirements to investigators and research personnel, • Participates in the Clinical Trials Monitoring Assistance Program (CTMAP) that includes oversight and monitoring of investigator/coordinator compliance with standard operating procedures as they pertain to the conduct of FDA regulated clinical trials., • Collaborates with the CTSA and the HRPO/IRB in developing programs such as programs to increase patient recruitment and to address regulatory and compliance needs., • Provides support of RecruitMe Platform for the CUIMC research community including:, • Coordinating with investigators and research teams in RecruitMe entry., • Developing training and process improvement projects, and other project management duties with RecruitMe., • Collaborating with the Director and Associate Director to implement objectives and workflow strategies for content maintenance on RecruitMe and other CTO websites., • Fulfilling reporting requirements for management, including metrics from Google Analytics data., • Monitoring external communications for social media websites., • Liaising with RecruitMe contacts, information technology ("IT") groups, CTSA leadership, outside vendors and/or internal partners in research for needs related to RecruitMe and other CTO websites., • Represents the Manager and Director in his/her absence and all other duties as assigned. Minimum Qualifications • Bachelor's degree, • In depth knowledge of federal, state and local laws and regulations and industry requirements and practices regarding the proper conduct of clinical trials:, • Particular knowledge and experience in FDA matters, including regulations relating to INDs and IDEs, • Expert working knowledge in GCP, patient safety standards and IRB regulations pertinent to clinical research, • Demonstrable ability to collaborate with partners in research, investigators and coordinators, • Excellent verbal and written communication skills, • Excellent interpersonal and presentation skills, • Strong computer skills required, including proficiency with content management systems, social media websites, Microsoft Office, • Ability to manage/handle multiple tasks, teams, and teamwork simultaneously. Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

The Eleanor and Lou Gehrig ALS Center of Columbia University invites applications for a full-time faculty position for a neurologist with expertise in amyotrophic lateral sclerosis (ALS) to serve as the Director of Clinical Trials. The successful candidate will join a multidisciplinary team dedicated to excellence in ALS patient care, research, and education. As Director of Clinical Trials, the candidate will play a key leadership role in developing, overseeing, and expanding the clinical trials portfolio focused on ALS and related motor neuron diseases. Key Responsibilities: • Lead and manage all clinical trial activities related to ALS within the ALS Center, including industry-sponsored, investigator-initiated, and NIH-funded studies., • Develop and expand our high-impact ALS clinical and translational research programs, fostering innovation and collaborations across departments and with external partners., • Oversee protocol development, study design, IRB submissions, regulatory compliance, budgeting, and monitoring., • Serve as Principal Investigator (PI) or Co-PI on clinical trials, ensuring scientific integrity, regulatory compliance, and patient safety., • Collaborate with basic science and translational research teams to align clinical trials with emerging therapeutic targets and biomarkers., • Mentor and supervise clinical research staff, fellows, and junior faculty involved in ALS research., • Participate in the evaluation, diagnosis, and clinical care of ALS patients within a multidisciplinary team setting., • Present findings at national and international conferences and publish in peer-reviewed journals., • Contribute to grant writing and fundraising activities to support clinical research infrastructure and innovation., • MD or DO degree with board certification in Neurology., • Completion of a Neuromuscular and/or ALS Fellowship strongly preferred., • Proven track record in ALS clinical research, including experience in conducting or overseeing clinical trials., • Eligibility for medical licensure in the state of New York., • Academic qualifications for a faculty appointment at the Assistant, Associate, or Full Professor level., • Strong leadership, organizational, and communication skills., • Experience as a Principal Investigator on multi-center clinical trials., • Involvement in national ALS research networks such as NEALS, CReATe, or ALS Association consortia. Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Job Description Summary Onsite #LI-Onsite East Hanover, New Jersey 200+ compounds in Novartis are supported by biostatisticians in 10+ sites around the globe. Biostatisticians transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. They influence decision-making in cross-functional international teams from early to late phase drug development. We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences. Come to an industry leader where you will lead implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level and you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial teams and other quantitative partners. Job Description Your Key Responsibilities: * Accountable for strategic statistical input and influence into one or more studies or projects. * Plan and execute exploratory analyses and statistical consultation within your cross-functional teams. * Lead development and implementation of innovation in statistical methodology and trial design. * Lead collaborations with medical and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans. * Propose and implement innovative designs and methods to optimize drug development. * Plan, prioritize and oversee study level activities and ensure efficient resource management within or across franchise and effective partnership with vendors. * Effective partnership with other functions to ensure integrated quantitative input into project. * Develop and mentor biostatisticians Video Link ___ This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. Role Requirements: * PhD with 6+ years' experience preferred or MS with 10+ years' experience with a degree emphasis in in Statistics, Mathematics or equivalent * Advanced knowledge of applying statistics and innovative approaches expert knowledge in a variety of statistical areas * Influences decisions that directly impact the project and department ability to deliver objectives * Record of successful implementation of novel methods and/or innovative strategies in drug development * Strong interpersonal and communication skills bridging scientific and business needs Desirable Requirements: * Prior experience with drug development needs and activities Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click ___. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: ___ You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: ___ EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Automation, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teams, Data Analytics, Decision Making Skills, Metadata Management, Statistical Analysis

The Eleanor and Lou Gehrig ALS Center of Columbia University invites applications for a full-time faculty position for a neurologist with expertise in amyotrophic lateral sclerosis (ALS) to serve as the Director of Clinical Trials. The successful candidate will join a multidisciplinary team dedicated to excellence in ALS patient care, research, and education. As Director of Clinical Trials, the candidate will play a key leadership role in developing, overseeing, and expanding the clinical trials portfolio focused on ALS and related motor neuron diseases. Key Responsibilities: • Lead and manage all clinical trial activities related to ALS within the ALS Center, including industry-sponsored, investigator-initiated, and NIH-funded studies., • Develop and expand our high-impact ALS clinical and translational research programs, fostering innovation and collaborations across departments and with external partners., • Oversee protocol development, study design, IRB submissions, regulatory compliance, budgeting, and monitoring., • Serve as Principal Investigator (PI) or Co-PI on clinical trials, ensuring scientific integrity, regulatory compliance, and patient safety., • Collaborate with basic science and translational research teams to align clinical trials with emerging therapeutic targets and biomarkers., • Mentor and supervise clinical research staff, fellows, and junior faculty involved in ALS research., • Participate in the evaluation, diagnosis, and clinical care of ALS patients within a multidisciplinary team setting., • Present findings at national and international conferences and publish in peer-reviewed journals., • Contribute to grant writing and fundraising activities to support clinical research infrastructure and innovation., • MD or DO degree with board certification in Neurology., • Completion of a Neuromuscular and/or ALS Fellowship strongly preferred., • Proven track record in ALS clinical research, including experience in conducting or overseeing clinical trials., • Eligibility for medical licensure in the state of New York., • Academic qualifications for a faculty appointment at the Assistant, Associate, or Full Professor level., • Strong leadership, organizational, and communication skills., • Experience as a Principal Investigator on multi-center clinical trials., • Involvement in national ALS research networks such as NEALS, CReATe, or ALS Association consortia. Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: ___ Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area. The Associate Director, Biostatistics provides technical and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds. This includes but is not limited to: identifying optimal study designs, defining data analysis strategies, authoring and implementing statistical analysis plans, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials. The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues. The Associate Director, Biostatistics, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. ESSENTIAL FUNCTIONS Primary duties/responsibilities: * Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material. * Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally. * Participates in vendor evaluation, selection, and management. * Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment. * Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing all required data in a way that supports a high-quality database for the planned analyses. * Authors and manages the implementation of statistical analysis plans. * Authors and reviews statistical and outcome sections of study reports and submissions. * Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities. * Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. Advanced degree in Statistics or a related statistical discipline and a minimum of 7 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment. • Special knowledge or skills needed and/or licenses or certificates required. Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies. * Demonstrated ability to manage biostatistics deliverables at the study level. * Demonstrated understanding and working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry. * Hands-on statistical programming skills using SAS and/or R. * Ability to influence without direct authority. * Excellent verbal and written communication and skills. * Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. * Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. * Excellent understanding of regulatory requirements and guidance documents • Travel requirements 5- 15% Expected Base Salary Range: $163,800 - $206,200. The base salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

• Job Type: Officer of Administration, • Regular/Temporary: Regular, • Hours Per Week: 35 Reporting directly to the Associate Director of Regulatory Science (the " Associate Director") of the Clinical Trials Office (the "CTO") of Columbia University's Vagelos College of Physicians & Surgeons ("VP&S") at Columbia University Irving Medical Center ("CUIMC"), the Recruitment Application Specialist assists the Associate Director in overseeing CTO's clinical research subject recruitment application ("RecruitMe") and other research applications. The clinical research subject recruitment application is a collaboration between the CTO and the Irving Institute for Clinical and Translational Research (the "CTSA"). The CTO assists investigators and academic/research staff in developing clinical trials at VP&S and provides administrative resources and infrastructure to build and sustain clinical trials research at VP&S. The Irving Institute for Clinical and Translation Research works to foster a multi-disciplinary scientific mindset to encourage collaboration between disciplines. The successful candidate will work with Investigators and the research team in providing essential support of RecruitMe and the CTO. Responsibilities The Recruitment Application Specialist is responsible for the following: • Working with the Associate Director, implements objectives and workflow strategies for keeping RecruitMe and other CTO websites and applications up to date and refreshed, ensuring that all content is effectively incorporated across websites of the CTO., • Leads and coordinates with Investigators and research teams in the gathering, documenting and managing of required documents for entering into RecruitMe and performing routine maintenance duties, including content revisions and updates., • Interprets clinical trial and protocol information and provide accurate summarizations., • Manages the training, maintenance and support of RecruitMe to the CUIMC clinical trials research community., • Creates, manages, and monitors external communications for social media websites and perform regular audits of social media content and related advertising., • Leads program for training and process improvement projects, and other project management duties with RecruitMe and other applications., • Performing regular audits of site content and users for timeliness, accuracy, style, and branding., • Assists the Investigators and research teams to implement revisions, as necessary., • Provides design element knowledge to RecruitMe and other applications for better end-user use., • Has ability to learn applications rapidly and disseminating applicable learnings to user base., • Generates reports for management, including metrics from system data, including Piwik Pro., • Provides project management for RecruitMe and related research applications and providing research team support and service., • Liaises with RecruitMe contacts to maintain on-going delivery of documentation for entering trials into system and coordination with data entry specialists., • Liaises with different information technology ("IT") groups such as CUIMC IT and/or outside vendors to resolve technical problems as the situation requires., • Liaises with internal partners in research such as Sponsored Projects Administration, the Institutional Review Boards (the "IRB") and the Irving Institute for Clinical and Translational Science. Bachelor's Degree or equivalent in education and experience and a minimum of 4 years of related experience required. * Additional Position-Specific Minimum Qualifications: • The candidate must be able to work independently with prior project management experience., • Demonstrate ability to collaborate with partners in research, Investigators and research teams., • Demonstrate an ability to understand clinical research and summarize research news and protocols in lay terms., • Excellent verbal, written and editorial communication skills with an attention to detail required., • Excellent interpersonal and presentation skills., • Ability to manage/handle multiple tasks, teams, and teamwork simultaneously. Columbia University is committed to the hiring of qualified local residents.

We are currently seeking a full-time Associate in Rehabilitation and Regenerative Medicine and Research Physical Therapist for the Programs in Physical Therapy, Department of Rehabilitation and Regenerative Medicine, at Columbia University Irving Medical Center. The primary role of the physical therapist will be to provide assessment and treatment to research patients while also expanding the research-related activities. The candidate should be highly motivated, interested in pediatric neuromuscular disease, have excellent clinical skills, and have an interest in academic research. We are seeking an individual who can establish a strong rapport with children, their families, and the interprofessional healthcare team. The candidate should possess strong assessment skills and be well-versed in the application of evidence-based practice. Effective writing and communication skills are essential. Computer skills are required, including proficiency with Microsoft Word, Excel, Outlook, and PowerPoint. This position requires a special individual who can perform well in both clinical practice and an academic research environment. Responsibilities include: • Clinical trial evaluation, spirometry testing, motor function testing, quantitative muscle testing and other clinical and research evaluations of neuromuscular and neurodevelopmental disorders patients, • Data collection and entry, scheduling, and preparation for study visits, • Monitoring adherence to regulatory requirements and good clinical practice, • Assist the investigators in the design, planning, and implementation of new research projects, • Assist in writing protocols, • Assist in maintaining research files, • Assist with teaching the Pediatric Doctor of Physical Therapy Coursework, • Assist with student advisement on Pediatric Research Practicum Projects, • Provide clinical services to pediatric patients in the Programs in Physical Therapy Faculty practice as needed. Minimum Requirements: • Physical Therapy License in New York State, • Terminal degree preferred (EdD, PhD), currently enrolled will be considered, • Effective writing and communication skills are essential, • Computer skills are required, including proficiency with Microsoft Word, Excel, Outlook, and PowerPoint Preferred Requirements: • Ability to work in teams, flexibility, and a positive attitude, • Experience with neuromuscular disease/SMA is helpful but not required Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

The Associate Director, Medical Science Liaison – Respiratory serves as a scientific expert in the field and an extension of the Medical Affairs organization. Strong understanding of the Medical Science Liaison function, clinical trial design, evidence generation, and US Medical Affairs principles

Job DescriptionManufacturing Associate II Allendale, NJ Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices. Facility and personnel specific responsibilities will be regulated by company's policies or client procedures being performed at each Cellular Production Facility. The ideal candidate must have a collaborative and inquisitive nature, must possess excellent organizational and verbal and written communication skills and be flexible in their working hours. • Performs any and all required processing and manipulation required to produce and assess safe and efficacious products, • Proficiently functions within an ISO Class 7 and 6 clean room environments, ensuring personal and product safety, • Consistently produce a high level of documentation accuracy and clarity, • Performs cryopreservation of products using DMSO base solutions and controlled-rate freezers, • Proficiently operate and maintain equipment according to designed procedures. Assigned responsibilities could include but is not limited to COBE 2991 cell washer, Clinimacs cell separator, Elultra cell separator, controlled- rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, CO2 incubators, liquid nitrogen freezers, microscopes, pipets, wave bioreactors, refrigerators, ultra- cold freezers, water baths, tube sealers, dry shippers, centrifuges, sterile connection devices, • Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints, • Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation., • Thawing and/or washing cryopreserved hematopoietic cell products either at the Clinical Site or in the facility as specified by standard operating procedures, • Performing facility and equipment duties such as periodic maintenance, preventive maintenance, for applicable methods and equipment, reporting facility and equipment problems to Assistance Manager, trouble-shooting facility and equipment problems as specified in standard operating procedures, • Notifying Management of any deviation that may occur during processing or during equipment maintenance., • Applies knowledge of processing principles and techniques to make good judgement and appropriate decisions, • Performs investigations for deviations and complete deviations and CAPA’s (Corrective and Preventive Actions) in a timely manner, • Supports technology transfers into GMP manufacturing operations, • Participate in the on-call programREQUIREMENTS, • BA/BS or Associate's Degree in a biologics or related field preferred, • 2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing, • Current Medical Technologist license or equivalent is a plus, • Aseptic/cell processing and clean room experience preferred, • Demonstrates tact and courtesy in dealing with others, • Strong work ethic, methodical approach to new challenges, • GLP and GMP experience a plus, • Must be able to work independently and with minimal supervision, • Able to work in fast paced environment at times under pressure and with tight deadlines, • Excellent organizational skills and attention to detail, • Good verbal and written communication skills, • Strong team-oriented interpersonal skills are essential, • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work a flexible schedule that may include nights, weekends and/or holidays, • Training Required; GMP, Gowning training/qualification, Aseptic process qualification (personal media fill), • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyWorking EnvironmentMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work in the cleanroom environment for extended period of timeMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The Revenue Associate supports accurate and timely revenue reporting for clinical research activities by analyzing, reconciling, and validating revenue data against clinical trial contracts, budgets, and operational milestones.

Job Description (Associate) Director, Clinical Scientist (Remote) Key Responsibilities • Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis., • Author and review clinical protocols, ICFs, CSRs and regulatory documents, • Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies., • Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders., • Support investigator meetings, advisory boards and data monitoring committee meetings, • Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area., • Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs., • Work closely with CRO’s and have a can do, proactive biotech mindset. Qualifications & Education · PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine). · Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry. · Direct Phase 3 oncology clinical trial experience required. · Demonstrate experience authoring and reviewing clinical documents. · Demonstrated strong experience in clinical trial execution and data interpretation. · Strong analytical, organizational, and communication skills. · Deep understanding of oncology clinical development, endpoints and regulatory expectations. Technical / Soft Skills · Excellent cross-functional communication and stakeholder management. · Ability to work collaboratively in a fast-paced, team-oriented environment. · Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Joining a small but highly effective Clinical Data Management team to support leading and overseeing all data management activities for clinical studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines. The Associate Director, Clinical Data Management will represent Compass Data Management in the USA, providing additional time zone coverage for international trials and acting as the Data Management SME in the US for Compass team members, external vendors and regulatory interactions. Under the direction of the UK head of Clinical Data Management, the Associate Director, Clinical Data Management is responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF). Location: Hybrid in our New York City office or remote in the East Coast. Reports to: Director, Clinical Data Management. Roles and responsibilities (Include but are not limited to): • Contribute or lead development of process initiatives including, DM SOPs, Work Instructions, best practice standards (including data collection standards and implementation of advanced data review technology (e.g. analytic reviews, implementation of AI), • Accountable and responsible for ensuring the delivery of high-quality data management deliverables and activities from protocol review through database closure and archiving, • Lead design of high-quality EDC CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints, • Lead the development of data set-up integration needs for eCOAs, ePROs, eConsent and other data collection technologies as required by the protocol, • Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines, • Perform, and/or oversee the complete and accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites, • Identify and implement the most appropriate study data management study status/KPIs; analytic checks, data integrity checks and reports to ensure data integrity across Compass portfolio, • Lead data management function in ongoing study CRO vendor selection, qualification, evaluation and oversight, • Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection, • Support or lead data management function for submissions, audits and regulatory inspections as required, • Leverage project management skills to support and oversee multiple projects outsourced and work in a cross-functional team environment, • May include line management of data management reports, • Bachelor's degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience, • A minimum of seven (7) years of clinical data management experience in the pharmaceutical or Clinical Research Organization setting, • Proven track record of strong project management skills and experience managing data management activities, • Experience in vendor selection, partnering, and management, • Expert understanding of clinical data lifecycle, including database design, data structure, database development and testing, query management, data quality review, and database lock procedures, • Late stage development (Phase III) and NDA experience are preferred, • Advanced working knowledge of data collection standards including CDISC, CDASH and experience with medical coding dictionaries (MedDRA and WHODrug), • Expert knowledge of 21 CFR Part 11 regulations and regulatory submission requirements, • Expert knowledge of clinical data collection systems including EDC, eCOA and other data collection technologies, • Excellent written and verbal communication skills Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$160,000—$200,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials, and ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology. Responsibilities: • Lead or participate in a cross-functional team of subject matter experts to define at least one of the following types of standards within the assigned therapeutic area: Data Collection, Data Review Rules, SDTM mapping, ADaM mapping and derivation, Study-level tables, listings, or figures, Product-level safety analysis displays, • Ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities, • Support educating the organization on the proper use of standards in pipeline activities by contributing to the development of training materials; communicate ongoing standard development activities across the organization, • Provide feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC, • Review and provide feedback on SDTM Trial Design Domains, • Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions, • Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation, • Other responsibilities include: representing AbbVie’s interests in industry standards development projects; staying current with industry standards such as CDISC, and the regulatory requirements related to their use; identifying improvements to the processes and content of standards, and driving those improvements to completion, • May manage 3 or more direct reportsQualifications Minimum Qualifications: • MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience, • Experience leading development of standards for data collection, tabulation, analysis and/or reporting, • Experience with at least two of the following standards: CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards, • Active participation in CDISC teams, • SAS or R programming experience, • Experience creating SDTM specifications or training others to use SDTM Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionRole Summary The Clinical Supply (Senior) Manager/Associate Director supports the cross-functional working team and independently plans and organizes tasks to meet specified objectives and timelines. This role manages supply planning and delivery of development products to clinic by supporting clinical supply inventory management, clinical supply packaging, labelling, interactive web response system (IWRS), distribution, and logistics planning. The Clinical Supply (Senior) Manager/Associate Director is responsible for clinical supply budget and tracking in addition to managing and executing the clinical supply chain for current and future clinical study programs at all development levels. This individual contributor role has a strong focus on late-stage program development and commercial launch readiness. The Clinical Supply (Senior) Manager/Associate Director also has oversight of vendors supporting Clinical Development Manufacturing Organization (CDMO), Secondary Packaging and Distribution, Comparator Sourcing. Primary Responsibilities • Own the coordination and execution of all clinical supply-related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for clinical programs, • Support IWRS User specifications and UATs, • Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs, • Manage supplier relationships with vendors including maintaining key performance metrics and budget/invoice tracking, review supply needs for study start-up, ongoing resupply strategies, contract negotiation, amendments and closeout requirements, • Evaluate vendor selection to support clinical study supply chain according to capability and fit, • Generate RFPs for vendor proposals with the ability to breakdown study protocols to support the supply strategy and communicate study needs to obtain vendor based budgeting or internal support, • Contribute program budget review and invoicing considerations as it relates clinical supply chain study management and capture any impacts, • Support the clinical program’s global supply chain in current and future clinical studies for clinical supply to commercial strategy. Oversee international depots and distribution as appropriate, • Support governance committees for global clinical operations and global clinical supply chain, • Ensure consistency across processes and develop tools to implement sustainable improvements, • Manage the execution of clinical supply strategy for specific clinical programs from early to late stage development with an understanding of commercial launch readiness, • Understand the roles and responsibilities of all functions represented on cross functional drug development teams to mitigate up and downstream operational deliverables., • Support regulatory filings including IND and BLA submission information as it relates to a global supply chain, • Provide regular updates to the TMF as per departmental requirements that comply with all regulatory requirements., • Participate in clinical study team meetings, align with study details, collaborate in meeting study objectives, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development), • Additional responsibilities as needed Required Skills and Qualifications, • Bachelor's degree in life sciences, business-related field, or supply chain management; Master’s degree in Supply Chain Management preferred, • Minimum 5 years of experience handling/leading clinical supply chain and logistics; development experience preferred; 10+ years experience (7 years experience with Master’s degree) for Associate Director level, • Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management strongly preferred, • Knowledge of clinical materials production processes and design strategy for patient dose kits supporting a clinical study design, • Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams, • Demonstrated ability to work in a highly matrixed environment and manage supply chain initiatives in a high performing team across all levels, • Experience in multi-functional areas (Clinical Operations, Medical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP, • Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment, • Extensive experience in planning and execution of investigational materials supply strategies

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. Responsibilities: • Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission., • Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics department., • Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements.Qualifications, • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or Mathematics., • Experience must be in clinical trials, • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo, • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 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Job DescriptionDescription: About the company Shengsheng Supply Chain Management is an international logistics company that provides professional and integrated solutions for global time and temperature-sensitive cargo transportation. Professionally serving the life science, biotechnology and pharmaceutical research industries, supporting the international end-to-end transportation of clinical trial products, samples, commercial drugs, and biological and IVD reagents worldwide. The scope of services ranges from cold chain transportation, warehousing to customs clearance. At the same time, the technology in cold chain packaging has also been certified by most organizations around the world, and has been praised by thousands of partners and customers. About the job We are looking for a Logistics Associate to join our growing team in New York. This role will work closely with the logistics associates, driver, and station manager. Responsibilities: • Collection/Delivery - Operates all assigned vehicles, single, tandem, or multi axle configurations, forklifts, etc. in accordance with established safety standards, proper vehicle operation techniques and specified time schedules. Acts as the face of Shengsheng for all shipment collections and deliveries and ensures that customer interactions are handled in a pro-active and professional manner at all times., • Packing - Prepares and packages of all specialist packaging and temperature controlled consignments of various temperature zones ensuring all mandatory procedures are adhered to. Re-packs and/or re-ice shipments where necessary and ensuring all mandatory procedures are adhered to., • Documentation - Ensures the correct documentation such as airway bill, delivery slips, and invoices are accurately completed and processed with the shipment. Be aware of the regulations covering the transportation, labelling and packaging of dangerous/hazardous substances and observe and comply with these regulations at all times. Completes necessary paperwork, including accurate logbooks, records of cargo and any other assigned record-keeping duties on a daily basis., • Loading/Unloading - Loads and unloads containers, pallets, or materials and products, safely on trucks, trailers, or railcars by hand or by forklift truck. When loading, ensures loads are evenly balanced and distributed from the front of the trailer to the back and from side to side, as well checks axle weights and loads them in accordance with the DOT regulations., • Warehouse - Performs all necessary duties to maintain a clean, tidy and safe warehouse, ensuring all materials are stored in the designated areas. Reports any shortfalls of packaging stock, to the appropriate person, to ensure minimal stock levels are always maintained. Ensures refridges, freezers and incubator/oven temperatures are checked and remain within prescribed parameters and maintain accurate records thereof. Requirements: Must-Have • GED degree, • Must hold a full, clean driving license, • Must have commercial van/truck driving experience, • Pharmaceutical delivery experience, • TSA Qualified, • Proven ability to work well under time pressure, • Demonstrates a passion for customer service, • Ability to check and maintain accurate documentation

Job Description THE ORGANIZATION The Center for Justice Innovation is a nonprofit organization dedicated to advancing community safety and racial justice. Since 1996, we’ve worked alongside communities, courts, and those most directly affected by the justice system to build stronger, healthier, and more equitable neighborhoods. With a team of over 900 staff and an annual budget of $130 million, the Center carries out its mission through three core strategies: • Operating Programs that pilot new ideas and address local challenges;, • Conducting original research to evaluate what works—and what doesn’t; and THE OPPORTUNITY Brooklyn Justice Initiatives (BJI) seeks to reengineer the experience of criminal court in Brooklyn, New York by providing judges and attorneys meaningful alternatives to bail, fines, and jail sentences. Operating out of Kings County Criminal Court, Brooklyn Justice Initiatives is a team of social service providers, court-based resource coordinators, and others who seek to improve the quality of justice. By providing meaningful pre-trial supervised release and post-conviction sentencing options, Brooklyn Justice Initiatives seeks to use an arrest as a window of opportunity to change the direction of a participant’s life and avoid the harmful effects of incarceration. Brooklyn Justice Initiatives is seeking a Compliance Specialist. Reporting to the Compliance Manager, the Compliance Specialist will implement and execute strategies to ensure accurate compliance tracking and reporting for the Supervised Release team at BJI. The Compliance Specialist will also assist all Brooklyn Justice Initiatives with compliance concerns, audits, and data collection and entry. The Compliance Specialist will ensure programmatic deliverables are being met and provide both internal feedback and written updates to the Court including defense attorneys, Assistant District Attorneys, clerks, and Judges on a regular basis. The Compliance Specialist is also responsible for working with the Compliance Manager, the Associate Director of Compliance, and other Compliance Specialists to oversee the accuracy of internal data and execute quality assurance of BJI’s practices. Responsibilities include but are not limited to: • Engage in routine auditing of Brooklyn Justice Initiatives programs including: program compliance and other internal audits;, • Track participants’ progress in accordance with all grant requirements;, • Coordinate with court staff to provide participants’ compliance, eligibility, and case status to stakeholders, including prosecutors, defense attorneys, clerks, and other court staff;, • Provide written case updates to the court and other court staff including compliance and non-compliance reporting;, • Generate daily and weekly compliance memorandums detailing participants’ mandates, upcoming court dates, and outcomes;, • Coordinate across BJI programming for cross-over participants also within the Alternatives to Incarceration program;, • Maintain appropriate participant information in electronic databases, including, but not limited to, data entry and collection, mandate information and court outcome information;, • Assist the Compliance Manager, Associate Director of Compliance and senior management with the development and implementation of new programs, protocols, initiatives, and/or interventions;, • Assist with training initiatives for program staff and new hires;, • Work closely with the Center for Justice Innovation’s Data Analytics & Applied Research team to improve quality assurance of all BJI programming;, • Review and analyze internal trends and practices to support programmatic evaluation;, • Attend all required staff meetings (clinical team, all staff, etc.) and trainings, which may include non-traditional business hours; attend project events after hours, with advanced notice as needed; and Position Location: Brooklyn, NY. Compensation: The compensation range for this position is $52,000 - $65,400 and is commensurate with experience. Benefits: The Center for Justice Innovation offers an excellent benefits package including comprehensive healthcare with a national network, free basic dental coverage, vision insurance, short-term and long-term disability, life insurance, and flexible spending accounts including commuter FSA. We prioritize mental health care for our staff and offer services like Talkspace and Ginger through our healthcare plans. We offer a 403(b) retirement plan with a two-to-one employer contribution up to 5%. Note: This position is part of the NOLSW, UAW 2320 bargaining unit. The Center for Justice Innovation is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We do not discriminate based on race, color, religion, gender identity, gender expression, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other category protected by law. We strongly encourage and welcome applications from women, people of color, members of the LGBTQ+ community, and individuals with prior contact with the criminal justice system. Our goal is to create a supportive and respectful environment where everyone, regardless of background or identity, feels valued and included. At this time, the Center is unable to sponsor or take over sponsorship of an employment visa. All applicants must be legally authorized to work in the United States at the time of application and throughout the duration of employment. Candidates are expected to provide accurate and truthful information throughout the hiring process. Any misrepresentation, falsification, or omission of material facts may result in disqualification from consideration, withdrawal of an offer, or termination of employment, regardless of when discovered. In compliance with federal law, all hires must verify their identity and eligibility to work in the United States and complete the required employment verification form upon hire. Please refer to the job posting for relevant contact information. If contact details are not provided, we kindly ask that you refrain from inquiries via phone or email, as only shortlisted candidates will be contacted. Powered by JazzHR vz7AWUlhzg

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements. Location: Hybrid in our NYC Office or remote in the East Coast. Reports to: Associate Director, Statistics and Data Management. Duration: 9-month contract. Roles and Responsibilities (Include but are not limited to): • Leading and coordinating the programming activities within agreed timelines, • Managing the reporting of studies internally and externally, • Programming outputs as stated in the analysis plan, • Working closely with study team members, mainly with the study statistician, • Reviewing of the Statistical Analysis Plan (SAP) and shells, • Create and review SDTM and ADaM study specifications, • Ensure programs, datasets, outputs are appropriate for regulatory submission, • Perform simulations and data modelling, • Perform Interim analyses, • Extensive years experience in statistical programming, • CDISC expertise, • Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R, • Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting, • Experience in performing quality control (QC) checks, • Extensive knowledge in regulatory submission process, • Good understanding of ICH guidelines and regulations such as 21 CFR Part 11, • Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions, • Ability to solve challenging problems and provide recommendations to mitigate risk, • Good communication skills - both written and verbal Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.