Statistical Project Leader

Role Summary

Statistical Project Leader (Associate Director) in Medical Affairs Biostatistics at Sanofi, leading evidence generation across Phase IIIB/IV trials, observational and real-world studies. Drive statistical strategy, develop innovative solutions, mentor teams, and work across cross-functional partners to communicate medical evidence to healthcare professionals, payers, and researchers. Based in Morristown, NJ or Cambridge, MA.

Responsibilities

• 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
• 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
• 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

Qualifications

• 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

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)
• Demonstrated strong project/study management, interpersonal and communication skills
• Good knowledge of pharmaceutical clinical development and medical affairs
• Extensive ability to apply advanced statistical analyses using SAS and/or R languages
• 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