Executive Director, Biostatistics/Biometrics
Description
Our client is an attractive Global Pharmaceutical Company located in Boston. They offer a very stable environment while also still remaining smaller/more lean; allowing for creativity, flexibility and visibility. They are currently seeking an Executive Director or Senior Director of Biostatistics/Biometrics to oversee a group of biostatisticians, data managers and programmers. In this position you will be responsible for strategy and general expertise within biostatistics while also having oversight/people management responsibilities across biometrics. You will furthermore take on leadership responsibilities within cross-functional Clinical Development teams.
Location
Boston, MA. Must be willing to work in-house 3-4 days per week.
Responsibilities
- People management and cross-functional leadership across the Biometrics function (Biostat, Stat Programming, and Data Management).
- Interact regularly with Clinical Development teams, serving as the highest level Biometrics expert.
- CRO/vendor management, assessment and negotiation.
- Lead IND/NDA submission strategy from a biometric point of view.
- Regulatory document review.
- Interact with the FDA and other regulatory authorities in relation to biometrics questions/concerns.
- Keep the Biometrics department up to date regarding latest trends/technologies.
Qualifications / Requirements
- Ph.D. required.
- 15+ years of biostatistics experience is required. Leadership experience and oversight of biometrics disciplines (data management, programming, etc.) is also required.
- Direct report experience is required.
- IND/NDA/BLA regulatory submission experience is highly preferred.
- CDISC experience is desired.
Cornerstone's Privacy Policy
Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission.