Director, Biostatistics Project Lead

Sanofi•Waltham, MA

6d•Onsite

About The Position

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.

Requirements

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.
Ability to represent Sanofi in cross-company activities such a consortiums or professional associations.

Nice To Haves

Experience in the relevant therapeutic area desired.

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.