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Sanofi

Statistical Project Leader

Sanofi, Cambridge, Massachusetts, us, 02140

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Job Title Statistical Project Leader

Location Morristown, NJ / Cambridge, MA

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.

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Medical Affairs Biostatistics team as Statistical Project Leader (Associate Director) to drive evidence generation across Phase IIIB & IV clinical trials, observational and prospective real‑world evidence studies.

You’ll have opportunities to develop innovative statistical solutions to generate and communicate medical evidence to healthcare professionals, payers, and the scientific community while leading cross‑functional teams and mentoring statistical talent.

Within our department of Evidence Generation and Decision Science, you’ll be supported by a Biostatistics group that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Main Responsibilities

Drive statistical strategy for Medical Affairs studies, including Phase IV trials, observational studies, and RWE projects.

Lead statistical contribution to Integrated Evidence Generation plans, ensuring scientific rigor, regulatory compliance, and stakeholder relevance.

Independently manage statistical aspects with minimal oversight while engaging leadership on strategic decisions.

Drive innovation by rethinking traditional workflows and implementing cutting‑edge statistical methodologies to accelerate evidence generation.

Oversee project planning, timelines, and resources across multiple studies.

Manage relationships with external partners (CROs, academic collaborators, DMCs).

Partner with Medical Affairs, Clinical Development biostatistics, Pharmacovigilance, Regulatory, HEOR, and other functions to align statistical approaches with business objectives.

Represent Statistics in regulatory interactions and scientific forums.

Proactively identify opportunities to streamline processes and leverage AI solutions to enhance project efficiency.

Mentor junior statisticians and statistical programmers.

Foster a culture of innovation, scientific excellence, and continuous improvement.

Champion quality standards while promoting operational efficiency.

Lead by example in adopting AI and automation tools to transform statistical workflows and unlock significant productivity gains.

About You

7+ years (MS) or 5+ years (PhD) of pharmaceutical industry experience in clinical trials and/or medical affairs.

Proven track record of delivering results in complex, fast‑paced environments.

Soft and Technical Skills

Broad knowledge and good understanding of advanced statistical concepts and techniques, including their application in observational and RWE studies (e.g., causal inference methods, target trial emulation, pragmatic clinical trials).

Strong project/study management, interpersonal and communication skills.

Good knowledge of pharmaceutical clinical development and medical affairs.

Advanced proficiency in SAS and/or R language.

Results‑driven mindset with ability to rethink and optimize workflows, challenging the status quo to drive continuous improvement.

Knowledge or experience with Artificial Intelligence or Generative AI is a plus.

Enthusiasm for leveraging AI and Generative AI technologies to reform statistical practices.

Education MS or PhD degree in Statistics or relevant fields.

Languages Highly effective communication in English, both oral and written.

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 through 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.

Develop a career as an influential statistician, continually learning about statistical innovation and applying your learnings on your projects.

Gain international clinical trial experiences and communicate with Health Authorities worldwide.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse 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, 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.

Shape the future of healthcare, empower clinical advancements as a visionary leader in a leading multinational pharmaceutical company.

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