Offres statistician à East Orange, New JerseyCréer des alertes d'emploi

Job Description Summary Onsite #LI-Onsite East Hanover, NJ About the role: We are in search of a Principal or Senior Principal Biostatistician 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 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: * Responsible for all statistical tasks on the assigned trials. * Protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. * Contribute to planning and execution of exploratory analyses and statistical consultation within your cross-functional teams. * Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. * Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. * Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. * Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings 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: Essential Requirements: * PhD with 3+ years' experience preferred OR MS with 7+ years' experience. Principal / Senior Principal level commensurate with experience. * Fluent English (oral and written) * Strong communication and presentation skills Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $119,700 and $222,300 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 $119,700.00 - $222,300.00 Skills Desired Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Roles and Responsibilities • Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors., • Can develop SAPs and iSAPs text and shells with no supervision., • Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction., • Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments., • High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques., • Has the ability to apply drug development knowledge during production of complex statistical analyses., • Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study., • Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers., • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management., • Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations., • Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)., • Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines., • Write blogs and/or white papers for posting on the company website.Requirements, • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred., • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required., • Submission experience (ISS/ISE)., • Has high level knowledge of drug development as it pertains to biostatistics., • Expert knowledge of scientific principles and concepts., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Good organizational skills., • High proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Excellent problem-solving skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. JwI5EB7jHW

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