Biostatistics Manager

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. 

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

The Senior Manager, Biostatistics will be responsible for leading the execution of statistical components of Corcept Development programs. This position will manage external statisticians and statistical programmers.

This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations on the design and execution of clinical trials in the Corcept portfolio
• 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, and validation statistical analyses results generated by CROs
• Partner with Statistical Programming in the evaluation of CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness
• 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

Preferred Skills, Qualifications, and Technical Proficiencies:

• 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