Full Job Description
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.
Main 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.
About You
Basic Qualifications:
• 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.
• Experience publishing research findings, technical articles, or industry insights is preferred.
• Excellent understanding of clinical development; broad knowledge and good understanding of advanced statistical concepts and techniques.
• Experience in Oncology, especially in solid tumors, is a plus.
• 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).
The salary range for this position is:
$178,500.00 - $257,833.33
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.