Statistical Project Leader

Job title: Statistical Project Leader

Location: Morristown, NJ / Cambridge, MA

About the job 

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. Ready to get started? 

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: 

Strategic Leadership & Scientific Excellence

• Drive statistical strategy for Medical Affairs studies, including Phase IV trials, observational studies, and statistical expertise on 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 

Project Management & Collaboration

• 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-powered solutions to enhance project efficiency 

Team Leadership & Development

• 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  

Experience:

• 7+ years (MS) or 5+ years (PhD) of pharmaceutical industry experiences 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 s