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Statistical Project Leader (Associate Director)

Company: Sanofi
Location: Manville
Posted on: May 15, 2024

Job Description:

At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 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. Required Education/Experience: PhD/MS in statistics or related discipline with at least 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. 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. #LI-Hybrid At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But 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. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at!

Keywords: Sanofi, New Brunswick , Statistical Project Leader (Associate Director), Executive , Manville, New Jersey

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