Biostatistics Franchise Lead

Sanofi; Waltham (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Sanofi Inc. seeks a Biostatistics Franchise Lead to shape data strategy for vaccines and guide a team of biostatisticians across development stages. You will translate analyses into scientific evidence and contribute to regulatory submissions while managing cross-functional resources.

You will collaborate with health authorities, drive innovations in study design, and lead strategic initiatives across the franchise in a matrix organization.

Qualifications

• PhD in Biostatistics or related field; 10+ years pharma biostatistics experience, or a Master’s with 15+ years in pharma.
• 3+ years of people leadership experience.
• Strong background in biostatistical methods across vaccines or drug development; end-to-end biostatistics management.
• Regulatory submissions experience and handling inspections.
• Regulatory requirements knowledge and GCP standards; ability to lead in a matrix organization.
• Fluent English required.

Responsibilities

• Lead the data and biostatistical sciences strategy for the vaccines portfolio, guiding design and development timelines.
• Guide biostatistical contributions to clinical development strategy and regulatory documents.
• Manage operational planning and resourcing for biostatistical contributions across franchise projects.
• Direct and develop biostatisticians through hiring, coaching, and performance management.
• Champion continuous improvement of the quantitative data sciences platform and participate in global strategy.
• Represent Sanofi Biostatistics in interactions with health authorities and external forums.

Skills

People leadership

Biostatistics methods

Regulatory submissions

Project management

Communication skills

Fluent English

Education

PhD in Biostatistics

Master's degree in Biostatistics

Job description

• 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.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• 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.

About you

Basic Qualifications:

• 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 improvement and project management approaches; Ability to lead through influence in a matrix organization, with strong project management, interpersonal, intercultural and communication skills ; Strong sense of accountability and ownership, with the ability to help others connect their work to the broader business context.

• Fluent English required.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.