Associate Statistical Project Leader

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* Job Title:

** Associate Statistical Project Leader

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* Location:

** Cambridge, MA, Morristown, NJ

** About the Job*
* Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

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.

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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* Main Responsibilities:

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* + 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 validty 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 in Statistics, or related quantitative discipline strongly preferred and will be given preference in candidate selection due to the advanced statistical methodology required for this role. MS in Statistics or related discipline required as minimum qualification.

+ A minimum of 3 years of pharmaceutical experience in clinical development, such as in Biotech, Pharma, Clinical Research Organizations (CROs), health authorities, or 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.

+ 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.

+ Play a critical role in accelerating Sanofi's leadership in the flagship therapeutic area of Immunology & Inflammation

+ Work closely with leaders and partners with diverse backgrounds, expertise and styles who are ready to help you succeed in the organization.

+ Embark on a fast track of professional growth and development, where you'll gain valuable skills via projects, connect with industry leaders, and position yourself for leadership roles in your field

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…