Sr Manager/Associate Director, Statistics at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledge of global regulatory guidance on statistical methods for analyses of clinical data, and global submission requirements
Experience with clinical trial design and execution
Ability to write statistical analysis plans (including mockup TLFs)
Experience in preparing regulatory documents (briefing documents, safety summary, efficacy summary)
Strong understanding of CDISC electronic data packages
Familiarity with statistical programming and validation
Ability to identify and anticipate potential problems in study design and analysis

Responsibilities

Partner with Clinical Development, Regulatory, Pharmacovigilance, Quality Assurance, and Commercial organizations on the design and execution of clinical trials in Corcept’s portfolio
Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
Participate in writing regulatory documents (briefing documents, safety summary, efficacy summary)
Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
Partner with Statistical Programming in the generation of statistical analyses for internal and external presentations, and validation of statistical analyses results generated in-house or by CROs
Partner with Statistical Programming in the evaluation of CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness
Oversee the execution of the statistical components of clinical studies in-house and by CROs and independent contractors
Negotiate and ensure on-time and quality delivery of CRO-generated analyses results
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 (including work instructions, templates, and forms)
Identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of studies, proposing and implementing solutions
Ensure consistency and adherence to standards across compounds and/or therapeutic areas

Skills

CDISC

Statistical Analysis Plans

Mockup TLFs

Clinical Trial Design

Regulatory Documents

Statistical Programming

Validation

ISS/ISE

Regulatory Guidance

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

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.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

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.

Differentiation

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.

Upsides

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.

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