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

R2739247 Director, Data and Statistical Strategy Leader of Digital Biomarkers in Digital Health (all genders) – Statistical Innovation Hub

Job Overview

Apply locations Frankfurt am Main Berlin time type Full time posted on Posted 23 Days Ago time left to apply End Date: March 1, 2025 (30+ days left to apply) job requisition id R2753955

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:

• 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 .

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.

Hybrid Position: #LI-Hybrid

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