Senior Project Biostatistics Lead- Vaccines

Role Summary

Lead Biostatistician for a medium complexity vaccine project (one or several indications) in clinical development and/or post-marketing stage. Responsible for all statistical aspects of clinical development, medical affairs plans, studies and submissions activities, ensuring quality, external relevance, and scientific validity. Location: Waltham, MA.

Responsibilities

• Develop end-to-end clinical development plan for the vaccine in collaboration with clinical/medical and global project teams.
• Collaborate with clinical and project teams to secure internal approval of the plan by governing bodies at platform and cross-platform levels.
• Propose alternative trial design options and innovative approaches with support from the Statistical Innovation team.
• Lead cross-functional teams through GO/NoGo criteria and evaluate probability of technical success.
• Work with clinical, pharmacovigilance, regulatory, and other teams to gain Health Authorities acceptance of plans; seek support from the Biostat Franchise Lead as needed.
• Oversee execution of clinical trials for the project: data capture, randomization, Statistical Analysis Plan, and analyses for primary/secondary objectives (efficacy, immunogenicity, safety); may lead the most complex/priority study.
• Communicate trial results internally (Key Results Memo) and collaborate cross-functionally to interpret results and assess strategic impact on the plan.
• Contribute to external communication of study results to Health Authorities.
• Accountable for statistical aspects of submissions for marketing authorization or label improvement: ensure robust data analyses to demonstrate benefits/risks and support label claims; ensure CDISC data packages meet Health Authority expectations.
• Represent statistics in cross-functional working groups; contribute to process optimization and standards.
• Represent Sanofi Vaccines in cross-company activities (consortia or professional associations); operate in a worldwide context with global contributors.
• Lead indirectly 6–12 FTEs for project activities and exercise leadership in cross-functional initiatives.

Qualifications

• Required: Ph.D. in Biostatistics, Mathematics or related field; minimum 6 years biostatistics experience in the pharmaceutical industry.
• Required: MS in Biostatistics, Mathematics or related field; minimum 8 years biostatistics experience in the pharmaceutical industry.
• Required: Proven experience in clinical development or post-marketing activities.
• Required: Strong project management and interpersonal skills.
• Required: Broad knowledge and understanding of advanced statistical concepts and techniques.
• Required: Ability to manage statistical aspects through regulatory interactions, submissions, and marketing authorization processes.
• Required: Effective English oral and written communication skills.

Skills

• Scientific rigor and organizational skills
• Strategic influencing and cross-functional collaboration
• Communication and interpersonal skills
• Ability to work effectively in a team
• Computer skills (SAS, R, Office)

Education

• Ph.D. in Biostatistics, Mathematics or related discipline, or
• MS in Biostatistics, Mathematics or related discipline