Associate Statistical Project Leader, Biostatistics

At Sanofi, we have a shared commitment to bring innovation and rigor to oncology clinical development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase studies under minimum supervision of statistical project leader and/or team leader. You will be supported by a Biostatistics Department that invests in the development of all our team members, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

Major Duties and Responsibilities:

Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters:

• Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
• Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Accountable for statistical aspects of clinical development plan.
• Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).
• Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
• Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties.
• Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
• Review submission documents, such as IND, NDA, BLA, CTE or CTD to ensure statistical validity and accuracy.
• Contribute to define and review the specific deliverables related to Transparency and Disclosure.

Required Education/Experience:

• PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience.
• Good knowledge of pharmaceutical clinical development, together with late phase and/or early phase experience.
• Broad knowledge and good understanding of advanced statistical concepts and techniques.
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (e.g., R).
• Demonstrated strong interpersonal and communication skills.
• Working experience in clinical development such as clinical plan development, strategic discussion of regulatory path, interactions with regulatory agencies or other external stakeholders

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.​​

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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