Job Title: Deputy Director - Senior Project Biostatistics Lead- Vaccines
Location: Swiftwater, PA Morristown, MA, Waltham, MA
About the Job
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.
Lead Biostatistician for medium complexity vaccine project in clinical development and/or post-marketing stage. Accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities, including quality, relevance to external stakeholders, and scientific validity.
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Act as a Senior Biostatistics Expert at vaccine project level:
Develop with other clinical/medical and global project team members the end-to-end clinical development plan. Contribute with clinical and project team members to the internal approval of the plan by governing bodies at platform and cross platforms level
Contribute with project team members to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostat Franchise Lead as needed.
Oversee for his/her project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, Analyses deliveries for primary and secondary objectives.
In charge of the most complex/priority study in the project. Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Ensure project team compliance with SOPs and departmental standards.
Communicate internally the trials results, and work cross-functionally on the scientific interpretation of the results and evaluation of strategic impact on the plan. Contribute to the external communication of the study results to Health Authorities.
Accountable for the statistical aspects of the submission for marketing authorization or label improvement.
About You
PhD/MS in Statistics/Biostatistics or related discipline with at least 6 years of pharmaceutical experience.
Proven experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders.
Broad knowledge and good understanding of advanced statistical concepts and techniques.
Demonstrated strong study management, interpersonal and communicationskills.
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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.