Senior Statistical Project Leader
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About the Job
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:
- 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.
- Oncology experience is required, with candidates bringing hands-on experience supporting clinical development programs within oncology. Solid tumor 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).
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA #LI-SA #LI-Hybrid #vhd 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.
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