Deputy Director - Senior Project Biostatistics Lead- Vaccines

Sanofi•Morristown, PA

1d•Hybrid

About The Position

As Deputy Director - Senior Project Biostatistics Lead - Vaccines within our R&D team, you will serve as a Senior Biostatistics Expert at the vaccine project level, playing a critical role in developing end-to-end clinical development plans and contributing to the advancement of life-saving vaccines. Biostatistics applies statistical methods to a wide range of topics in biology, encompassing the design of biological experiments, the collection and analysis of data from those experiments, and the interpretation of the results. In this role, you will develop clinical development plans with clinical/medical and global project team members, contribute to gaining Health Authorities acceptance of these plans from a statistical standpoint, and oversee the execution of clinical trials including data capture, randomization, Statistical Analysis Plans, and analyses deliveries for primary and secondary objectives. You will be responsible for the most complex/priority studies in the project, mentor team members, promote teamwork, quality, operational efficiency, and innovation, while ensuring project team compliance with SOPs and departmental standards. Additionally, you will communicate trial results internally, work cross-functionally on the scientific interpretation and strategic impact evaluation, contribute to external communication of study results to Health Authorities, and be accountable for the statistical aspects of submissions for marketing authorization or label improvement. 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.

Requirements

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.

Responsibilities

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.