Director, Biostatistics Project Lead
Sanofi · Waltham, MA · 1 mo ago
HybridFull-time
About the role
Provide leadership and guidance as the lead biostatistician on one or more project team(s) and cross-functional teams, accountable for all statistical aspects of project(s). Act as statistical consultant within the company. Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale and shape the future of immunization.
Responsibilities
- Lead large business-critical vaccine project(s) (one or several indications) in either clinical development or post-marketing stage. With minimal Biostat Franchise Lead oversight, take accountability in directing the biostatistical contribution and in providing scientific leadership for related projects.
- Oversee statistical aspects of clinical development/medical affairs plans, studies, and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g., regulatory authorities, medical journals), and scientific validity.
- Mentor and lead global Biostatistical and Scientific Programming team members located in France, the U.S., China, or India. Promote global teamwork, quality, operational efficiency, and innovation. Create a productive work environment. Ensure project team compliance with SOPs and departmental standards.
- Plan and track Global Biostatistical Sciences activities, timelines, and resource use globally. Provide justification for planned resource needs. Optimize resource utilization through efficient and well-managed allocation. Respond to unscheduled increases in project workload.
- Ensure productive collaborations with other functions within the project team and in communicating with senior leadership.
- Represent biostatistics in cross-functional working groups within or outside Sanofi. Contribute to operational process optimization and provide inputs to statistics standards.
Requirements
- PhD or MS in statistics or a related discipline with at least 8 years of pharmaceutical experience.
- Demonstrated strong project management, interpersonal, and communication skills.
- Broad knowledge and good understanding of advanced statistical concepts and techniques.
- Proven experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies, or other external stakeholders.
- Experience in the relevant therapeutic area desired.
- Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.
Benefits
- Discover endless opportunities to grow your talent and drive your career, whether through promotion or lateral moves, 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 reflecting 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.