Director, Statistical Programming at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Deep knowledge of key statistical analyses and patient populations for compound(s)
Excellent business acumen, presentation, communication, and negotiation skills
Ability to drive meaningful change across all levels of the Biometrics organization
Ability to anticipate issues and propose solutions
Knowledge of department guidelines, CDISC standards, SDTM, ADaM, TLFs specifications, and FDA guidance
Stay current with regulatory requirements on CDISC and clinical regulatory programming standards, including therapeutic area-specific standards

Responsibilities

Oversee all programming activities on assigned compounds to ensure high quality and timely deliverables, including successful management of timelines, anticipating issues, proposing solutions, planning and executing meetings/presentations, tracking project timelines, and working collaboratively cross-functionally
Ensure department guidelines are followed and modeled for all deliverables, including development and validation of statistical programming deliverables
Help grow robust procedures for dataset development and delivery, including developing novel approaches to validation (e.g., using R)
Contribute to establishing operational processes and standards for the statistical programming group, including templates for SDTM, ADaM, and TLFs specifications
Maintain transparent communication with department head, peers, and team members on timelines and goals, including communicating status of key milestones, explaining statistical programming concepts/complex algorithms, and planning/conducting meetings to set expectations and timelines
Manage internal and external (CRO) programming resources to ensure on-time and quality delivery, including defining scope, reviewing progress/activities, and ensuring appropriate skill sets are assigned
Evaluate CDISC electronic data packages for completeness and ensure submission readiness of study data packages per CDISC standards and FDA guidance
Contribute to initiatives for a new programming environment to host clinical data

Skills

Statistical Programming

CDISC

Clinical Data Standards

Biometrics

Drug Development Programming

SAS

SDTM

ADaM

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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