Statistical Project Leader (Associate Director)

6-11 years

Not Disclosed

Bridgewater

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Job:

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biostatistics team in the Statistical Innovation Hub as a Statistical Project Leader and you'll be supporting our Neuroscience division with your talents in psychometric analysis expertise to establish novel digital endpoints.

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 Statistical Project Leader (Associate Director) in our Statistical Innovation Hub, you will provide technical expertise in psychometric analysis to support establishment o novel digital endpoints or re-engineering of existing endpoints from (digital) clinical outcome assessments (COAs). You will be accountable for relevant technical analysis plans (eg, psychometric analyses for assessing validity, reliability and responsiveness of the variable of interest) and be expected to play a key role in the process of defining (digital) COA endpoints through close collaboration with relevant stakeholders.

Provide technical expertise in psychometric analyses to assessg validity, reliability and responsiveness in Clinical Outcome Assessments (COAs) including PROs (Patient-Reported Outcomes), e-PRO and dCOAs (digital COAs) for establishing novel digital endpoints or re-engineered endpoints from existing COA/PRO, with minimal guidance or direction.
Closely work with statistical project leaders across projects and provide fit for purpose strategy for analysis of relevant endpoints, collaborating with other statistical methodology experts as necessary.
Oversee execution of the related psychometric analyses; perform and/or coordinate with vendors and programmers to deliver related analyses; provide insight into interpretation and discussion of results supporting the clinical study report, regulatory discussions and/or publications.
Provide insights into other steps to define COA endpoints (eg, content validity, analytic validity, usability). Ensure productive collaboration with other functions (e.g., Patient Centered Outcomes, AI/digital, etc), promoting teamwork, operational efficiency, and innovation. Represent Statistics in scientific or technology working groups or cross functional initiatives.
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:

PhD/MS in statistics or related discipline with 5 (7 for MS) years of related experience (establishing a novel endpoint of digital COA or ePRO in clinical trials, psychometric analyses).
Expert knowledge of psychometric analyses methods of assessing clinical validity as well as multi-factorial analysis
Good understanding of content validity, analytic validity and usability and handling digital/large longitudinal data.
Good understanding of clinical development. Broad knowledge and good understanding of advanced statistical concepts and techniques, with the capability to quickly acquire knowledge in new statistical frontiers.
Demonstrated potential leadership and great interpersonal/communication skill as well as in project management.
Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.
Advanced R programming skills and good understanding of SAS programming. Knowledge in other computer languages is a plus.
Fluent oral and written English language

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.

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.

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Statistical Project Leader (Associate Director)

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