Deputy Director - Senior Project Biostatistics Lead - Vaccines

Job Title: Deputy Director - Senior Project Biostatistics Lead
- Vaccines

• Location:
  
  Swiftwater, PA Morristown, MA, Waltham, MA

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.

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.

• 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.

• 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 communication skills.

• 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 Affïquative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national…