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At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Director, Biostatistical Consulting (SrDBiosC) to join our A-team (office-based*/remote). As a (SrDBiosC) at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. This includes management of direct reports, ensuring appropriate resourcing allocation, and supporting business development and proposal needs. This position contributes to the department, the business unit, and Allucent financial and operational goals. The SrDBiosC, interacts with the BIOSC team and Allucent biostatistics and statistical programming team members, direct reports, executive leadership, other Allucent functional groups and business units. This position maintains compliance with relevant SOPs, regulatory guidelines, and client expectations. The SrDBiosC, provides statistical consulting to sponsors to support clinical program development, protocol development, sample size and endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions. The SrDBiosC is a senior member of BIOSC and supervises according to the organizational chart. In this role your key tasks will include: • Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions, • Provide statistical consulting for complex and/or novel statistical analyses, • Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams, • Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable, • Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study, • Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity, • Execute a statistical analysis of any complexity as specified in a protocol or analysis plan, • Interpret and communicate results for complex statistical analyses and outputs, • Develop and/or review the statistical sections of a study protocol for studies of any complexity level, • Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses, • Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications, • Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports, • Working knowledge of SAS® for production and validation of datasets and statistical outputs, • Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts, • Working knowledge of CDISC standards, • Review CRF design to ensure it conforms with the study protocol and analysis needs, • Review data management documents as requested to ensure integrity of study data, • Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing, • Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings, • Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value., • Identify high-risk or high-impact deliverables and assign appropriate oversight, • Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process, • Collaborate with and verify open communication with other functional areas and business units, • Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams, • Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients, • Provide key input into project proposals and budgets, • Establish positive relationships with current and future clients, • Identify key accounts and maintain strong long-lasting relationships to win new and repeat business, • Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming, • Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations, • Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare, • Must have strong experience in Bayesian designs specifically in oncology studies., • Minimum 15 years of relevant work experience, • Minimum 10 years of experience in drug development and/or clinical research, • Thorough knowledge of GxP, • Strong familiarity with relevant regulations and guidelines, • GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements, • Working knowledge of computer systems, applications and operating systems, • Demonstration of critical thinking and analytic skills, • Broad knowledge of drug development, • Ability to simplify complex issues into understandable concepts, • Proficient with one or more sample size software packages, • Strong technical skills with proficiency in SAS and/or other statistical programming languages, • Strong written and verbal communication skills including good command of English language, • Collaborative and client-focused, • Ability to work in a fast-paced challenging environment of a growing company, • Administrative excellence, • Strong leadership skills, • Effective at problem solving, strategic thinking and conflict resolution, • Strong presentation and networking capabilities, • Excellent organizational, negotiating and financial skills, • Knowledge of SAS, • Proficiency with various computer applications such as Word, Excel, and PowerPoint, • Strong individual initiative, • Excellent attention to detail and commitment to quality, • Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors, • Ability to effectively manage multiple tasks and projects, • Comprehensive benefits package per location, • Competitive salaries per location, • Departmental Study/Training Budget for furthering professional development, • Flexible Working hours (within reason), • Opportunity for remote/hybrid* working depending on location, • Leadership and mentoring opportunities, • Participation in our Buddy Program as a new or existing employee, • Internal growth opportunities and career progression, • Financially rewarding internal employee referral program, • Access to online soft-skills and technical training via GoodHabitz and internal platforms Disclaimers: *Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our ___. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-Remote #LI-Hybrid #LI-TCW

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Key Responsibilities: • Lead the biometrics team including statistician, data manager, and statistical programmer at a program level., • Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies., • Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies., • Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings., • Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data., • Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines., • CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines., • Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities., • Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses., • Build and develop efficient biostatistical processes and standards., • Other duties as assigned. Ideal Candidate: • PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry., • Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology and causal inference is preferred., • Experience with regulatory submissions and interactions with regulatory agencies., • Proficiency in statistical software (e.g., SAS, R) and data management systems., • Experience with CDSIC including SDTM, ADaM, CDASH., • Successful track record of working independently in a matrixed organization and providing solutions to emerging problems., • Excellent communication and interpersonal skills, along with organizational skills., • Ability to work collaboratively in a multidisciplinary team environment., • Experience in people management is preferred. What We Offer: • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly., • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits., • Unlimited PTO, • Two, one-week company-wide shutdowns each, • Commitment to provide professional development opportunities., • Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

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