Sr. Director Biostatistics
- Biostatistics | FDA Experience | Clinical Development
- Boston, MA
- $240,000 - $260,000 + complete benefits package
A Biotech company is looking to hire a Sr. Director Biostatistics that would be responsible for all biostatistics functions in support of the biotech's late phase clinical development programs. The Sr. 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 Sr. Director Biostatistics will have responsibilities that include:
- Overseeing all of biostatistics, programming, and data management teams
- Serving as the leader for FDA/EMA 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/EMA guidelines
- 7+ years of experience in managing biostatistics teams
- Oncology experience strongly preferred
- Excellent verbal and written skills
- D. in Biostatistics or related field
