Director, Biostatistics Project Lead

Job Title: Director, Biostatistics Project Lead

• Location: Waltham, MA

About the job

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 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.

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:

• Lead large business critical vaccine project (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 project. The accountability covers for 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 involved and located in France/US/China or India.  Promote global teamwork, quality, operational efficiency, and innovation. Create 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.  Seek to optimize resource utilization through efficient and well-managed resource allocation.  Capacity to respond to unscheduled increase in project workload.

• Ensure productive collaborations with other functions within the project team and in communicating with senior leadership.

• Represent biostatistics in cross function working groups within or outside Sanofi. Contribute to operation process optimization and provide inputs to statistics standards.

About you:

Required Education/Experience:

• PhD/MS in statistics or 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 a 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 a 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; affect