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Study Lead Statistician

Cambridge, Massachusetts, Bridgewater, New Jersey

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Overview

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  • Results-driven
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Culture: Play to Win

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

Job Summary

Lead one or several late phase studies (incl. Onco early development and MA); lead one or several standard non-Onco early development projects, under minimum supervision of statistical project leader and/or team leader

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) and/or clinical development plan (CDP) for early phase project, 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 an strategy for standard non-oncology early development projects
  • 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 insure statistical validity and accuracy
  • Contribute to define and review the specific deliverables related to Transparency and Disclosure
  • Provide technical guidance to junior staff.
  • Plan and track study/project activities and timelines.
  • Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.
  • Represent statistics to participate in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.

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 (R, …)
  • Demonstrated strong interpersonal and communication skills

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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