Associate Director, Statistical Programming 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

Experience in statistical programming
Knowledge of CDISC standards and regulatory programming
Familiarity with SAS programming
Understanding of clinical trial data management

Responsibilities

Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report
Develop specifications, build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses
Manage on-time and quality delivery of CRO-generated analyses results
Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and output displays
Validate data and results of statistical analyses generated by CROs
Manage internal programming resources for study deliverables as applicable
Stay current with regulatory requirements on CDISC and clinical regulatory programming standards
Utilize CDISC implementation guides and industry validation software to check compliance of CDISC data packages (SEND, SDTM, and ADaM, define.xmls and reviewer’s guides)
Evaluate CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness as applicable
Participate in standards governance and developing biometric department operational processes as applicable

Skills

SAS

CDISC

SDTM

ADaM

SAS Macros

Statistical Analysis Plans

Clinical Trial Data Management

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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