Associate Statistical Project Leader

Role Summary

Join Sanofi as an Associate Statistical Project Leader in Biostatistics Immunology & Inflammation (I&I).

Location:

Cambridge, MA;
Morristown, NJ. You will lead several I&I phase 2 or 3 studies under the minimum supervision of the statistical project leader and/or team leader and develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. This role sits within the Evidence Generation and Decision Science department with a focus on delivering robust statistical insight to support patient outcomes.

• 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.

• Required:
  
  MS in Statistics or related discipline; minimum qualification.
• Preferred:
  PhD in Statistics or related quantitative discipline; strongly preferred.
• Required:
  
  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.
• Required:
  
  Broad knowledge and good understanding of advanced statistical concepts and techniques; being able to do advanced statistical analyses using SAS or R.
• Required:
  
  Proficient in written and spoken English.

• SAS
• R
• Statistical programming
• Data analysis
• Study design

• MS in Statistics or related discipline; minimum qualification.
• PhD in Statistics or related quantitative discipline (preferred).