Senior Statistical Project Leader

Sanofi•Morristown, MA

1d•Hybrid

About The Position

Our Evidence Generation and Decision Science (EGDS) group at Sanofi unites Biostatistics, Clinical Statistical Modeling, and Real-World Evidence to revolutionize data-driven decision making through cutting-edge quantitative science and deliver unparalleled integrated evidence that drives innovation and scientific breakthroughs. Join our EGDS Biostatistics Oncology team as Senior Statistical Project Leader (Director) and you’ll provide statistical leadership, guidance, and strategic input for clinical studies in one large or impactful projects in solid tumors. You’ll have opportunities to develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. EGDS will support your growth through people development and inclusive career opportunities that value diversity of thought and abilities, cultivating future leaders to shape the next generation of clinical science. 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.

Requirements

PhD in Statistics or related discipline with at least 8 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, Clinical Research Organizations (CROs), health authorities or academic clinical research centers.
OR MS in Statistics or related discipline with at least 10 years of pharmaceutical experience in clinical development, including experience with Biotech, Pharma, Clinical Research Organizations (CROs), health authorities or academic clinical research centers.
Excellent understanding of clinical development; broad knowledge and good understanding of advanced statistical concepts and techniques.
Proven successful experience in clinical development such as submissions, interactions with regulatory agencies or other external stakeholders.
Demonstrated leadership and excellent interpersonal/communication, project management skills.
Exhibited expertise to represent organizations in cross-company activities (e.g., consortiums or professional associations).

Nice To Haves

Experience publishing research findings, technical articles, or industry insights is preferred.
Experience in Oncology, especially in solid tumors, is a plus.

Responsibilities

Serve as a strongly recognized statistical domain leader in both statistical as well as relevant clinical knowledge in the disease domain (solid tumors) to support efficient clinical development planning and study design.
Provide advanced level of statistical and scientific contributions to clinical development plans, protocol, SAP, CSR, regulatory documents, studies and submissions activities (when applicable), and provide strategic statistical leadership for responsible projects in Sanofi’s solid tumor pipeline.
Plan, monitor and manage multiple complex projects directly, including trial activities, timelines, processes, and resources to ensure operational excellence and align practices in compliant with Sanofi SOPs and Biostatistics standards.
Develop productive collaboration with other functions in the aligned project team, with other statistics project leaders, and in communicating with senior leadership.
Represent statistics in challenging regulatory meetings (ex: EOP2, Type B/C/D, or Advisory Committee meetings), key scientific or technology working groups or cross function initiatives.