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Sanofi Group Senior Statistical Project Leader (Director) in Cambridge, Massachusetts

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Our Team:

At Sanofi, we have a shared commitment to bring innovation to a broad and diverse portfolio of therapeutics supported by our Biostatistics and Programming department.

You will be part of a group that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

Main responsibilities:

As a Senior Statistical Project Leader (Director) in our Statistical Innovation Hub, you will serve as the expert lead statistician in digital biomarkers for defining novel digital endpoints or re-engineering existing endpoints from digital Clinical Outcome Assessments (COAs). You will act as a go-to person in digital biomarkers and provide technical guidance to other project/study statisticians, stakeholders and junior staff.

  • Lead the provision of technical expertise in psychometric analysis of clinical validity (reliability and responsiveness) in digital COAs for establishing novel digital endpoints or re-engineering endpoints from existing ones and provide expertise in analytic approaches to large amounts of (intensive longitudinal) data created by digital endpoints.

  • Closely work with statistical project leaders across projects and guide a fit for purpose strategy for analysis of relevant endpoints, collaborating with other statistical methodology experts as necessary.

  • Provide profound insights into the other steps (content validity, analytic validity and usability) to define novel digital endpoints. Ensure productive collaboration with other functions (e.g., Patient Centered Outcomes, AI/digital, etc), promoting teamwork, operational efficiency, and innovation. Represent Statistics in internal scientific or technology working groups or cross functional initiatives.

  • Guide execution of the related psychometric analyses; oversee interpretation and discussion of results supporting the clinical study report, regulatory discussions and/or publications.

  • Provide technical guidance to junior staff or other project statisticians or stakeholders.

  • Participate in professional activities, including serving as a contributing member or leader of working group(s)/committees/professional organizations, or serving as a scientific journal reviewer.

Required Education/Experience:

  • PhD/MS in statistics or related discipline with at least 7 (9 for MS) years of clinical development experience in pharma/biotech industry and should have at least 4 years of leading experience in development of digital biomarkers (establishing a novel digital biomarker or digital COA or ePRO in clinical trials). PhD is preferred.

  • Expert knowledge of psychometric analysis methods and multi-factorial analysis and excellent knowledge of analytic approaches to large amounts of (intensive longitudinal) data created by digital endpoints.

  • Excellent insight to other steps in defining novel digital endpoints such as content validity, analytic validity and usability, in addition to the expert knowledge in psychometric analysis.

  • Excellent understanding of clinical development. Broad knowledge and great understanding of advanced statistical concepts and techniques, with the capability to quickly acquire knowledge in new statistical frontiers.

  • Demonstrated leadership and excellent interpersonal/communication skill as well as in project management.

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

  • Advanced R programming skills and good understanding of SAS programming. Knowledge in other computer languages is a plus.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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.


At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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 ( !