About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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.
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.
Cambridge, MA
As the specialty care global business unit of Sanofi, we are focused on rare diseases, rare blood disorders, multiple sclerosis, oncology and immunology. More than 30 years since we began, we remain just as committed to and passionate about advancing therapies that offer hope to patients and families.
Our approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. Founded as Genzyme in Boston in 1981, we rapidly grew to become one of the world’s leading biotechnology companies, recognized for our pioneering development of treatments for rare genetic disorders and our innovative contributions to medical science and biomanufacturing.
Genzyme became part of Sanofi in 2011. While continuing to focus on rare diseases, we also established ourselves as a leader in the field of multiple sclerosis. In 2016, our focus expanded to include Sanofi’s programs in oncology and immunology. In 2018, with the acquisitions of Bioverativ and Ablynx, we further expanded our focus to include rare blood disorders, bringing deep expertise in hematology.
Our ambition is to be the industry leader in specialty care. We currently provide more than 25 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.
Driven by our commitment to patients, we strive to develop strong relationships with our patient communities, listening to their perspectives so that we can truly understand their needs. These collaborations continue to guide and motivate us as we work to push the boundaries of medicine and technology to develop new and better therapies where none existed before.