Corcepttherapeutics
Associate Director, Biostatistics
Redwood City, California, United States. Posted 4 months ago
The role
The Associate Director of Biostatistics will lead the execution of statistical components of Corcept Development programs. This person will manage external statisticians and statistical programmers.
What you will do
- Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials
- 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
- Partner with Statistical Programming in generation of statistical analyses for internal and external presentations
- Partner with Statistical Programming in the validation of statistical analyses results generated by CROs
- Partner with Statistical Programming in the evaluation of CDISC electronic data packages
- Stay current with regulatory requirements for statistical methods of analyses and scientific developments
- 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
Required qualifications
- Applicants must be currently authorized to work in the United States on a full-time basis
Nice to have
- 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
- Demonstrated ability to apply complex statistical methods, conduct and interpret the results
- D. 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 CROs
About the company
Corcept is focused on the science of cortisol. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists.