Associate Statistical Project Leader

Role Summary

Associate Statistical Project Leader in the Biostatistics Immunology & Inflammation group at Sanofi. Location: Cambridge, MA; Morristown, NJ. You will lead several I&I phase 2 or 3 studies under minimal supervision and develop statistical solutions to support critical trial decision-making and advancement of therapies across drug development.

Responsibilities

• Provide high quality input into the design of the clinical study, including protocol development, setup and conduct to ensure data are captured to answer study objectives and support planned statistical analyses.
• Accountable for all statistical deliverables related to the study, including statistical sections in protocol (sample size calculation, randomization specifications, statistical methodology), the Statistical Analysis Plan, data surveillance, and CSR analyses.
• Effectively utilize external groups, such as CROs or data monitoring committees (DMC).
• Work with the programming team to provide definitions, documentation and review of derived variables, and participate in the quality control plan.
• Perform and coordinate statistical analyses, review statistical data distributions and properties.
• Oversee execution of analyses according to the SAP, prepare statistical methods and provide insight into interpretation and discussion of results for the CSR and publications, ensuring statistical integrity and regulatory compliance.
• Propose, prepare and perform exploratory and ad hoc analyses as relevant to study objectives.

Qualifications

• Required: A minimum of 3 years of pharmaceutical experience in clinical development (Biotech, Pharma, CROs, health authorities, or academic clinical research centers).
• Required: Broad knowledge of advanced statistical concepts and techniques; ability to perform advanced statistical analyses using SAS or R.
• Required: Proficient in written and spoken English.

Education

• Required: MS in Statistics or related discipline.
• Preferred: PhD in Statistics or related quantitative discipline.