Deputy Director - Senior Project Biostatistics Lead- Vaccines
BioSpace · Swiftwater, PA · 1 wk ago
AnalystFull-time
About the role
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.
Main 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.
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 communications skills.
Why Choose Us
- Pursue Progress. Discover Extraordinary.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- 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.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.