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Senior Manager / Associate Director Biostatistics

Employer
Corcept Therapeutics
Location
Menlo Park, CA
Start date
Jul 10, 2022

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Job Details

Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity.

In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2021, we generated revenue of $366 million and net income of $112 million.

The Senior Manager / 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. This position can be hybrid (Bay Area) or remote (West Coast hours).

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

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.

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

Company

Corcept is leading the discovery and development of drugs that modulate the effects of cortisol.
 
Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases.  Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since being founded in 1998.
 
Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity.  To support this mission, Corcept collaborates with numerous basic scientists and clinical researchers to find better ways to improve patient lives.
 
Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases driven by cortisol dysregulation.

Stock Symbol: CORT

Find Us
Website
Location
149 Commonwealth Drive
Menlo Park
California
94025
United States
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