Statistical Project Leader, Associate Director
Cambridge, Massachusetts, Bridgewater, New Jersey
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At Sanofi, we have a shared commitment to bring innovation and rigor to medical affairs and post-marketing support.
As Statistical Project Leader, you will be responsible for developing, coordinating, and performing all statistical work, strategic, scientific, and operational, in support of medical affairs and post-marketing for several projects in rare disease and rare blood disorders therapeutic area. You will be supported by a Biostatistics and Programming Department that invests in the development of all our team members, offering compelling career opportunities that value diversity of opinions and talents, to optimize overall success and have a meaningful impact on patients’ lives.
Major Duties and Responsibilities:
Lead several projects in medical affairs and post-marketing in rare diseases and rare blood disorders.
Develop collaborative relationships and work effectively with the biostatistics and programming team, medical leads, publication leads, and other members of the study/brand teams.
Work in a cross-functional team to define the medical affairs and post-marketing evidence generation plan.
Lead the development and execution of statistical aspects for Sanofi sponsored clinical trials (such as phase IV, pragmatic and prospective RWE studies), including contribution to study trial design, protocol development, analysis planning, study results presentation and interpretation, clinical study report authoring and publications.
Review publications, marketing materials, and education and training materials that contain clinical data and product claims.
Statistical reviewer of study outlines for Sanofi sponsored local trials and investigator sponsored trials.
Stay informed with data being generated in current clinical development programs and by competitors.
Plan and track project activities, timelines, and resource use.
Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary.
Promote teamwork, quality, operational efficiency, and innovation.
Represent statistics in regulatory interactions (e.g. for post-approval commitment, label-enhancement).
PhD in statistics or related discipline with at least 6 years of pharmaceutical experience.
Demonstrated strong project/study management, interpersonal and communication skills.
Broad knowledge and good understanding of advanced statistical concepts and techniques.
Broad knowledge of pharmaceutical clinical development.
Broad experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders.
Ability to be flexible and adapt quickly to the changing needs of the organization.
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.
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.
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