Senior Project Biostatistics Lead; Associate Director - Vaccines

Job Title: Senior Project Biostatistics Lead (Associate Director) - Vaccines

Location: Waltham, MA

Lead Biostatistician for medium complexity vaccine project (one or several indications) in clinical development and/or post‑marketing stage. The incumbent is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

• Act as a Senior Biostatistics Expert at vaccine project level.
• Develop with other clinical, medical and global project team members the end‑to‑end clinical development plan for the vaccine.
• Contribute to the internal approval of the plan by governing bodies at the platform level (e.g. RAfS) and cross‑platform level (e.g. STRC, CRSF, jSRC).
• Propose alternative trial design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.
• Lead the cross‑functional team through GO/No
  
  Go criteria and evaluate probability of technical success.
• Contribute with project team members (clinical, pharmacovigilance, regulatory) to gain Health Authority acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed.
• Oversee for the project the execution of the respective clinical trials: data capture, randomization, statistical analysis plan, analyses deliveries for primary and secondary objectives (efficacy, immunogenicity, safety). May be in charge of the most complex/priority study in the project.
• Communicate internally the trial results (Key Results Memo) and work cross‑functionally (clinical, safety, immunology) to the scientific interpretation of the results and evaluation of strategic impact on the plan.
• Contribute to the external communication of the study results to Health Authorities.
• Accountable for the statistical aspects of the submission for marketing authorization or label improvement:
  • Ensure appropriate and quality data analyses are available efficiently to demonstrate the vaccine benefits‑risks and support the label claims.
  • Ensure quality of the clinical data CDISC packages are delivered and comply with Health Authorities (e.g. FDA, PMDA, CDE, KFDA) expectations.
• Represent statistics in cross‑function working groups, contribute to operation process optimization and provide inputs to statistics standards.
• Represent Sanofi Vaccines in cross‑company activities such as consortiums or professional associations.
• Operate in a worldwide context with GBS contributors located in different sites (France, US, China, India) with different cultures.
• Lead indirectly 6‑12 FTEs for delivering the different project activities and make trade‑off decisions on the priorities with the global project team.

• Interact with other GBS teams, Clinical, Regulatory, Global Program Head, Immunology, Medical Writing, Data Management.
• Have regular interactions with senior R&D leaders to communicate complex statistical concepts.
• Represent Sanofi Vaccines for external activities.

• Accountable for all biostatistics aspects related to the development, submission, launch and life‑cycle management of a medium vaccine project (5‑7 clinical studies and global submission in key markets) or a major vaccine program with support from the Biostatistics Franchise Lead.
• Lead indirectly 6‑12 FTEs, make trade‑off decisions on priorities and ensure deliveries according to Vaccines GBU scorecards.
• Make decisions in any cross‑functional initiatives where representing the platform.

• Ph.D. in Biostatistics, Mathematics or related…