Senior Project Biostatistics Lead (Associate Director) – Vaccines

Senior Project Biostatistics Lead (Associate Director) - Vaccines at Sanofi Group in South Waltham, Middlesex County is a full‑time role that provides statistical leadership for vaccine development initiatives.

About the Role

This position serves as the primary biostatistical expert for one or more vaccine indications, guiding the design, analysis, and interpretation of studies from early clinical phases through post‑marketing support. The incumbent works closely with cross‑functional teams to ensure that statistical considerations are integrated into clinical development plans, medical affairs activities, and regulatory submissions.

What You'll Do

• Provide strategic statistical input for vaccine protocols, including sample size calculations, randomization schemes, and endpoint definitions.
• Oversee the execution of statistical analysis plans, ensuring accuracy and compliance with regulatory guidelines.
• Lead the preparation of statistical sections for clinical study reports, investigator brochures, and submission documents.
• Collaborate with clinical, data management, and safety teams to monitor study progress and address emerging statistical issues.
• Mentor junior statisticians and promote best practices in biostatistical methodology within the vaccine portfolio.
• Contribute to internal scientific forums and external presentations, representing the statistical perspective on vaccine projects.

What We're Looking For

• Advanced degree (PhD or MS) in Biostatistics, Statistics, or a related quantitative field.
• Proven experience leading statistical activities for vaccine or biologics programs in clinical development or post‑marketing settings.
• Strong knowledge of statistical methodologies applicable to infectious disease trials, including adaptive designs and immunogenicity assessments.
• Proficiency with SAS, R, or comparable statistical software and familiarity with CDISC standards.
• Excellent communication skills, with the ability to convey complex statistical concepts to non‑statistical stakeholders.
• Demonstrated ability to manage multiple projects simultaneously while maintaining high quality and timelines.

About Sanofi Group

Sanofi is a global healthcare leader dedicated to improving access to innovative medicines and vaccines. The company fosters a collaborative environment where scientific expertise drives solutions that protect and enhance public health across diverse therapeutic areas.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.