Associate Director, Statistical Programming - Menlo Park, United States - Corcept Therapeutics

Description

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

Reporting to the Head of Statistical Programming, the Associate Director is responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical trial results. This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department as applicable

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 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, 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.

Preferred Skills, Qualifications or Technical Proficiencies:

• In depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
• In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
• In-depth knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer's guides (SDRG, ADRG)
• Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred
• Familiarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plus
• Ability to operate independently in unstructured situations
• Ability to communicate technical information to a non-technical audience

Preferred Education and Experience:

• Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred)
• 10+ years of experience in clinical trial development (late stage preferred)
• FDA/EMEA submission experience a plus
• Demonstrated ability for project management of statistical programming projects in clinical development
• Experience managing delivery of statistical programming projects by CROs
• Able to navigate uncertainty with creative problem solving
• Ability to take a hands-on, "roll up your sleeves" approach
  The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,000- $250,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education." Applicants must be currently authorized to work in the United States on a full-time basis.

This position is based in Menlo Park, CA and will be onsite, typically 3 days per week.

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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.

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Corcept is an Equal Opportunity Employer

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