Director, Biostatistics Project Lead

Job Title:

Director, Biostatistics Project Lead

Location:

Waltham, MAAbout 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.

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.

• 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.

• 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.

• 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…