Sanofi Group Senior Manager Statistician in Bridgewater, New Jersey
At Sanofi, we have a shared commitment to bring innovation and rigor to our competitive program, from bench to bedside. Our global department 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.
Provide leadership and guidance as the lead statistician on one or more project team(s) in I&I disease areas, accountable for methodological and statistical aspects of project(s). Contribute to clinical development plan, trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
Provide support and leadership to the clinical trial study and/or project team on 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 statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, statistical analysis results for CSR.
Provide statistical support to clinical development plan a 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.
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.
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.
PhD 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.
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.
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.