Senior Statistical Project Leader

BioSpace; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi is seeking a Senior Statistical Project Leader (Director) within the Evidence Generation and Decision Science (EGDS) Biostatistics Oncology team in the United States. The role provides statistical leadership for clinical studies in solid tumors and opportunities to develop innovative statistical solutions across all phases of drug development.

The ideal candidate will have a PhD or MS with extensive pharma experience, a track record in regulatory interactions, and strong leadership and

Qualifications

• PhD in statistics or related field with 8+ years pharma clinical development experience.
• MS in statistics or related field with 10+ years pharma clinical development experience.
• Experience publishing research findings is preferred.
• Strong understanding of clinical development and advanced statistical concepts.
• Experience in Oncology, especially solid tumors, is a plus.
• Proven experience in submissions and regulatory interactions.
• Demonstrated leadership, interpersonal/communication and project management skills.
• Experience representing organizations in cross-company activities.

Responsibilities

• Serve as a statistical domain leader to support efficient clinical development planning and study design.
• Provide advanced statistical contributions to plans, SAP, CSR, regulatory documents, studies and submissions activities, and provide strategic statistical leadership for responsible projects in solid tumor pipeline.
• Plan, monitor and manage multiple complex projects directly, including trial activities, timelines, processes, and resources.
• Develop productive collaboration with other functions and communicate with senior leadership.
• Represent statistics in regulatory meetings and cross-functional initiatives.

Skills

Statistical leadership

Project management

Interpersonal communication

Cross-functional collaboration

Education

PhD in Statistics

MS in Statistics

Job description

About The Job

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. 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 youll provide statistical leadership, guidance, and strategic input for clinical studies in one large or impactful projects in solid tumors. Youll 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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples 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 Sanofis 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).

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 its 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.

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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.