Associate Statistical Project Leader

Job Title: Associate Statistical Project Leader

Location: Morristown, NJ, Cambridge, MA

About The Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biostatistics Immunology & Inflammation (I&I) as Associate Statistical Project Leader and you will lead several I&I phase 2 or 3 studies under minimum supervision of statistical project leader and/or team leader. You’ll have opportunities to develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. Within our department of Evidence Generation and Decision Science, you’ll be supported by a Biostatistics group that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• 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.
• 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 and scientific validity 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.
  
  

About You

• PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience in clinical development, including experience with Biotech, pharma, Clinical Research Organizations (CROs), health authorities and academic clinical research centers
• Broad knowledge and good understanding of advanced statistical concepts and techniques; being able to do advanced statistical analyses using SAS or R.
• Demonstrated strong interpersonal and communication skills.
• Proficient in written and spoken English
  
  

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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