Full-Time
Associate Director
Biostatistics
Confirmed live in the last 24 hours
Corcept Therapeutics
201-500 employees
Develops cortisol modulators for medical conditions
Compensation Overview
$215.3k - $253.3kAnnually
Senior, Expert
San Carlos, CA, USA
- 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
- Ph.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
- 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.
Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.
Company Stage
IPO
Total Funding
$119.1M
Headquarters
Menlo Park, California
Founded
1998
6 month growth
↑ 4%1 year growth
↑ 10%2 year growth
↑ 31%
Simplify's Take
What believers are saying
- Significant investments from firms like Intrinsic Edge Capital and Jackson Creek Investment Advisors indicate strong market confidence in Corcept's growth potential.
- The appointment of experienced leaders like Roberto Vieira and Monica Tellado suggests a strategic focus on expanding into oncology and emerging markets.
- Corcept's commitment to patient and medical education enhances its reputation and fosters better patient outcomes.
What critics are saying
- Ongoing legal disputes, such as the antitrust lawsuit from Teva, could result in financial and operational setbacks.
- The loss of the Korlym patent lawsuit to Teva poses a significant threat to Corcept's revenue stream from its flagship product.
What makes Corcept Therapeutics unique
- Corcept Therapeutics specializes exclusively in cortisol modulation, setting it apart from broader-focused biopharmaceutical companies.
- Their flagship product, Korlym, is the first FDA-approved treatment for hypercortisolism in Cushing's syndrome, giving them a unique market position.
- Corcept's extensive R&D pipeline with over 1,000 discovered selective cortisol modulators highlights their commitment to innovation in this niche field.