Director Biostatistics
- Biostatistics | FDA Experience | Neurology
- Greater Philadelphia Area
- $200,000 - $240,000 + complete benefits package
A Biotech company is looking to hire a Director Biostatistics that would be responsible for all biostatistics functions in support of the biotech's late phase clinical development programs. The Director Biostatistics will play a key role in designing new clinical programs and protocols as well as working to lead regulatory submissions and global health outcome efforts.
The Director Biostatistics will have responsibilities that include:
- Overseeing all of biostatistics, programming, and data management teams
- Serving as the leader for FDA meetings and Advisory committee meetings
- Act as an active member of the protocol development team by providing statistical insight and guidance
- Contributing to vendor section and management
- Providing operational statistical expertise for early to late phase clinical trial programs
- Writing and reviewing SAP as well as statistical protocols and SOPs
The ideal candidate will have the following skill set:
- 10+ years in biostatistics in life sciences preferred.
- Experience with managing complex statistical data and with analytic statistical software
- Experiencing with modelling and bootstrapping methods
- Experience with FDA regulatory submissions
- Familiarity with CDISC relating to FDA guidelines
- Neurology/CNS experience strongly preferred
- Excellent verbal and written skills
- Ph.D. in Biostatistics or related field
