Statistical Project Leader

Role Summary

Statistical Project Leader (Associate Director) in Sanofi’s Medical Affairs Biostatistics team. Drive evidence generation across Phase IIIB & IV clinical trials, observational studies, and prospective real-world evidence studies. Develop innovative statistical solutions to communicate medical evidence to healthcare professionals, payers, and the scientific community while leading cross-functional teams and mentoring statistical talent. Location: Morristown, NJ or Cambridge, MA.

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

Qualifications

• Required: 7+ years (MS) or 5+ years (PhD) of pharmaceutical industry experience in clinical trials and/or medical affairs
• Required: Proven track record of delivering results in complex, fast-paced environments

Skills

• Broad knowledge of advanced statistical concepts and techniques, including 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
• Extensive ability to apply advanced statistical analyses using SAS and/or R
• Results-driven mindset with ability to rethink and optimize workflows
• 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