Statistical Project Leader

Sanofi; Cambridge (MA); Hybrid; USD 149,000 - 215,000; Full time

Job summary

Sanofi in Cambridge, MA is seeking a Statistical Project Leader to steer statistical leadership for one or more late-phase rare disease projects. You will guide trial design, analysis plans, and regulatory interactions, while mentoring junior statisticians and collaborating with cross-functional teams.

Join the Rare Disease & Rare Blood Disorders area to develop innovative statistical solutions and support critical decision-making across drug development, contributing to advances in therapy and

Qualifications

• PhD or Master's in statistics or related quantitative field.
• Experience leading statistical activities in pharma or biotech projects.
• Mentoring and guiding junior statisticians.

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.
• Direct statistical support and provide scientific leadership for responsible project with minimal direction.
• Accountable for statistical aspects of early or late clinical development plans, studies and submissions, ensuring quality and regulatory relevance.
• Mentor people working on the project and promote teamwork, quality, efficiency, and innovation.
• Create a productive work environment and ensure SOP/compliance adherence by the team.
• Plan and track project activities, timelines, and resource use; justify planned resources.
• Optimize resource utilization across projects and cross-functional areas.
• Effectively utilize external groups (CROs, DMC) and manage workload fluctuations.
• Provide technical guidance and mentoring to junior staff.

Skills

Statistical leadership

Project management

Mentoring

Education

PhD or Master's degree in Statistics/Biostatistics/Applied Mathematics/Data Science

Job description

Job Title: Statistical Project Leader Location: Cambridge, MA

About The Job: 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.

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 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 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.

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 Affluent Action employers committed to a culturally diverse 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; 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.

#GD-SA #LI-SA #vhd #LI-Onsite Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affluent Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only The salary range for this position is: $148,500.00 - $214,500.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.