Statistical Project Leader

Sanofi•Morristown, MA

14h•Onsite

About The Position

Join our Rare Disease & Rare Blood Disorders area and you’ll provide statistical leadership and guidance as the lead statistician on one or more project teams. You’ll have opportunities to develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. Sanofi 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 Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

PhD or Master's degree in Statistics, Biostatistics, Applied Mathematics, Bioinformatics, Computational Biology, Data Science, or related quantitative/scientific discipline
PhD holders, minimum 5 years of experience or Master holders, minimum 7 years of experience in pharmaceutical, biotech/biologics, medical device/diagnostics or related industries
Academic or research experience may be considered

Nice To Haves

Demonstrated strong project/study management skills
Broad knowledge and good understanding of advanced statistical concepts and techniques
Broad knowledge of pharmaceutical clinical development
Broad 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
Demonstrated strong interpersonal and communication skills
Ability to represent Sanofi in cross-company activities such as consortiums or professional associations

Responsibilities

Lead one moderate project, one or several indications, or a highly complex large study in late phase rare disease development; lead multiple projects including at least one complex project.
With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project.
Accountable for statistical aspects of early or late 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 people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment.
Ensure project team compliance with SOPs and departmental standards.
Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas.
Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).
Capacity to respond to unscheduled increase in project workload.
Provide technical guidance and mentoring to junior staff.
Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
Represents statistics in regulatory meetings
Represents statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.