Sr. Manager Biostatistics
Responsible for leading the execution of statistical components of Corcept Development programs. This position will manage external statisticians and statistical programmers.Responsibilities
- Partner with Clinical Development, Regulatory, Manufacturing and Commercial organizations on design and execution of clinical trials in Corcept portfolio.
- Partner with Statistical Programming in generation of statistical analyses for internal and external presentations, and validation statistical analyses results generated by CROs.
- Partner with Statistical Programming in evaluation CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness.
- Oversee execution of the statistical components of clinical studies by CROs and independent contractors. Manage on-time and quality delivery of CRO generated analyses results.
- Stay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trials.
- Consult internal audit team in assessing regulatory compliance of CROs with respect to statistical SOPs
- Participate in standards governance and development of Corcept Biostatistical SOPs.
- PhD in Statistics, Biostatistics, or Mathematics
- 5+ years of experience in clinical trial development
- Demonstrated ability for project management of projects in clinical development
- Experience managing delivery of statistical projects by CRO
- Demonstrated ability to apply complex statistical methods, conduct and interpret the results
- Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirements
- Proficiency with statistical programming in SAS. Familiarity with SAS/GRAPH, SAS/MACRO, and R.
- Familiarity with CDISC SDTM and ADaM specifications and associated regulatory guidance
- Excellent analytical, communication and organizational skills
Position Location – Must be located in the North California/Bay Area. Out of state applications will only be considered if you have indicated that you are willing to relocate to the Northern California/Bay Area.