R2739247 Director, Data and Statistical Strategy Leader of Digital Biomarkers in Digital Health[...]

About the job

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 Data and Statistical Strategy Leader of Digital Biomarkers in Digital Health (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.

About you

Experience:

• 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).
• 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.

Soft and technical skills:

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

Education:

• PhD/MS in statistics or related discipline; PhD is preferred.

Languages:

• Fluency in English.

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.

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer.

Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Hybrid Position: #LI-Hybrid