Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
The Associate Director of Biostatistics will be 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 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.
- Demonstrated ability to apply complex statistical methods, conduct and interpret the results
Preferred Education and Experience:
- 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
The pay range that the Company reasonably expects to pay for this position is $215,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
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Top Skills
What We Do
Leading the field in the discovery of drugs that modulate the effects of cortisol.
The adverse effects of excess cortisol have been Corcept’s focus since the company’s inception. Abnormal levels and release of cortisol play a role in a variety of metabolic, oncological, and psychiatric diseases, and we are currently studying a new generation of compounds that may mitigate the effects of excess cortisol.
