Statistical Project Leader

BioSpace; Cambridge (MA); On-site; USD 160,000 - 210,000; Full time

Job summary

Sanofi in Cambridge, MA is seeking a Statistical Project Leader to provide statistical leadership as the lead statistician on one or more project teams within Rare Disease & Rare Blood Disorders. You will guide trial design, analysis strategies, and critical decision-making across development stages.

Join a team that leverages AI-powered research to drive breakthroughs and patient impact. The role offers opportunities for mentorship, collaboration across functions, and ongoing professional

Qualifications

• PhD or Master's degree in Statistics, Biostatistics, or related quantitative field.
• Minimum 5 years (PhD) or 7 years (Master) in pharma/biotech/related industries.
• Experience with clinical development, submissions, and regulatory interactions preferred.

Responsibilities

• Lead one moderate project or multiple indications in late-phase rare disease development.
• Direct statistical support and provide scientific leadership for responsible projects.
• Mentor project team members and ensure SOP compliance.
• Plan and track activities, timelines, and resource use; optimize utilization.
• Provide technical guidance to junior staff and collaborate with senior leadership.
• Represent statistics in regulatory meetings and cross-functional initiatives.

Skills

Statistical leadership

Mentor staff

Project management

Regulatory communication

Education

PhD or MSc in Statistics/Biostatistics

Job description

About The Job

Join our Rare Disease & Rare Blood Disorders area and youll provide statistical leadership and guidance as the lead statistician on one or more project teams. Youll 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.

Job Title: Statistical Project Leader

Location: Cambridge, MA

About The Job

Join our Rare Disease & Rare Blood Disorders area and youll provide statistical leadership and guidance as the lead statistician on one or more project teams. Youll 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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving peoples 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 peoples lives.

Main Responsibilities

• Lead one moderate project, one or several indications,or a highly complexlarge 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
• Represent 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.

About You

Basic Qualifications:

Education

• PhD or Master's degree in Statistics, Biostatistics, Applied Mathematics, Bioinformatics, Computational Biology, Data Science, or related quantitative/scientific discipline

Experience

• 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

Preferred Qualifications

• 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

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 its 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.
• 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.
• Achieve genuine work-life balance in a supportive R&D environment.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affi... 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; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.