Biostatistics Franchise Lead

Job title:

Biostatistics Franchise Lead

Location:

Morristown, NJ / Morristown, NJ / Waltham, MA

About the job:
As Biostatistics Franchise Lead within our Biostatistical & Clinical Data Sciences team, you'll bring quantitative leadership and strategic direction to a portfolio of vaccines development programs, acting on translating science into real-world protection. Ready to get started? Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.

Join the engine of Sanofi's mission — where deep immuno-science meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. As the accountable biostatistical interface for your franchise, you will bring effective expertise into vaccines development and lifecycle strategy, leading a team of biostatisticians across varying levels of seniority and project complexity.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

• Lead the data and biostatistical sciences strategy for your franchise's vaccines portfolio, bringing strategic guidance, coherence, prioritization, and innovative study designs that optimize development timelines, cost, and probability of success.
• Guide the biostatistical contribution to clinical development strategy, including development scenarios for business planning, decision by design practice, functional review of regulatory documents and ensure translation of biostatistical analyses into scientific evidences and quantitative risk assessments, accounting also for external data
• Manage operational planning and resourcing for biostatistical contributions across franchise projects (clinical and medical), preparing budget and staffing estimates, allocating workload, and collaborating with other franchise leads and hubs to share resources according to business priorities
• Direct and develop the biostatisticians within your franchise through hiring, coaching, mentoring, and performance management, while managing contractors and matrix relationships where resources span multiple franchises.
• Champion continuous improvement of the broader quantitative data sciences platform, contribute to and help execute the global Biostatistical Sciences strategy and roadmap, leading functional or cross-functional initiatives and representing the team's voice in wider organizational efforts
• Represent Sanofi Vaccines Biostatistics in interactions with health authorities and in external biostatistical forums and working groups.

• PhD in Biostatistics or a related field, with 10+ years of relevant biostatistics experience in pharmaceutical industry , or a Master's degree with with 15+ years of relevant biostatistics experience in pharmaceutical industry.
• 3+ years of people leadership experience, with direct people management experience preferred.
• Strong background in biostatistical methods applied across all phases of vaccines or drug development, with proven experience managing biostatistics activities end-to-end;
  Working knowledge of key regulatory guidance documents with proven experience in regulatory submissions, and experience addressing inspection or audit findings.
• Expert understanding of biostatistics and programming processes and tools, along with related regulatory requirements, and a strong command of clinical trial and good clinical practice standards;
  Solid understanding of vaccine or drug development, with practical knowledge of process…