Associate Director/Director Biostatistics
- Biostatistics | FDA Experience | CNS/Neurology
- Boston, MA
- $180,000 - $230,000 +complete benefits package
A growing biotech company in the Greater Boston area is looking to hire an AD/Director Biostatistics candidate that would be responsible for all biostatistics and data analysis functions in support of clinical development programs. This candidate will play a key role in designing new clinical programs and protocols as well as working to lead regulatory submission and global health outcome efforts.
The AD/Director Biostatistics will have responsibilities that include:
- Overseeing all of biostatistics and data analysis 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
- 5+ years of experience in managing biostatistics teams
- CNS/neurology experience preferred but not required
- Excellent verbal and written skills
- Masters or Ph.D. in Biostatistics or related field
