Full-Time

Director – Data and Statistical Strategy Leader of Digital Biomarkers in Digital Health

Statistical Innovation Hub

Confirmed live in the last 24 hours

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA + 1 more

More locations: Bridgewater Township, NJ, USA

Hybrid position requiring in-office presence.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
R
Data Analysis
Requirements
  • 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.
Responsibilities
  • 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).
  • 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.

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical conditions. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline and a global presence. The company's goal is to enhance health outcomes and improve the quality of life for individuals worldwide.

Company Stage

Grant

Total Funding

$2B

Headquarters

Paris, France

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Sanofi's strong financial performance, as evidenced by its raised 2024 outlook, indicates robust growth and stability.
  • The company's strategic investments in innovative biotech firms, such as Ventyx Biosciences, enhance its pipeline and potential for breakthrough therapies.
  • Sanofi's Dupixent receiving a positive recommendation for expanded use in children demonstrates its leadership in addressing unmet medical needs.

What critics are saying

  • The highly competitive pharmaceutical market requires Sanofi to continuously innovate to maintain its market position.
  • Regulatory challenges in different regions could delay product approvals and impact revenue streams.

What makes Sanofi unique

  • Sanofi's extensive R&D efforts and strategic partnerships, such as with Orano Med for radioligand therapies, set it apart in the competitive pharmaceutical landscape.
  • The company's global reach and focus on patient-centric solutions allow it to effectively navigate diverse regulatory environments and deliver innovative treatments worldwide.
  • Sanofi's investment in sustainable initiatives, like SureChill's 'Cooling as a Service' model, highlights its commitment to addressing healthcare challenges in emerging markets.

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