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Job Description
Arvinas, a clinical-stage biotechnology company, is seeking an Executive Director of Biostatistics and Data Management. This role is crucial for developing and implementing strategic plans for Arvinas' clinical developments. The Executive Director will provide technical support for ongoing clinical trials, FDA submissions, publications, and other business needs. This position reports to the Chief Medical Officer and can be remote, hybrid, or located at the headquarters in New Haven, CT.
Role involves:
- Leading the biostatistics strategy in all Arvinas clinical development projects.
- Providing statistical leadership into clinical development plans, protocol development, and statistical analysis plans.
- Overseeing CRO and statistical vendors to ensure the quality of all statistical deliverables.
- Collaborating cross-functionally with clinical research, regulatory strategy, and medical affairs.
- Developing and implementing department standards and practices.
- Building and mentoring the biostatistics talent team at Arvinas.
- Overseeing and developing the data management team.
- Identifying opportunities to utilize innovative statistical methodology.
- Incorporating generative AI into the workflow.
Requirements:
- 15+ years of experience in pharmaceutical/biotech clinical drug development.
- 10+ years of oncology experience.
- Past NDA/BLA submission experience is preferred.
- Proficiency in statistical programming languages/software such as SAS, R, etc.
- Extensive knowledge of FDA/ICH guidelines and CDISC standards.
- In-depth knowledge of the global drug development process.
- Excellent written and oral communication skills.
- Must be legally authorized to work in the US.
- Ph.D. in Statistics, Biostatistics, Mathematics, or a related field.
Arvinas offers:
- Competitive package of base and incentive compensation.
- Comprehensive benefits program.
- Opportunities for innovation and growth.
