Full-Time

Associate Director

Statistics

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulators for medical conditions

Biotechnology
Healthcare

Compensation Overview

$215.3k - $253.3kAnnually

Senior

San Carlos, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
R
Requirements
  • 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
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.

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

$39.7M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

3%

1 year growth

2%

2 year growth

-3%
Simplify Jobs

Simplify's Take

What believers are saying

  • Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.
  • Advancements in drug delivery systems could enhance Corcept's product efficacy.
  • The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

What critics are saying

  • Teva's antitrust lawsuit could lead to legal expenses and market share loss.
  • Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.
  • Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

What makes Corcept Therapeutics unique

  • Corcept specializes in cortisol modulation, a niche with few direct competitors.
  • Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.
  • Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

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Benefits

Remote Work Options

Flexible Work Hours