Associate Director, Statistical Programming
About The Position
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’s 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 advancing 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.
Requirements
- 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)
- Ability to operate independently in unstructured situations
- Ability to communicate technical information to a non-technical audience
- 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)
- Demonstrated ability for project management of statistical programming projects in clinical development
- Experience managing delivery of statistical programming projects by CROs
- Ability to navigate uncertainty with creative problem solving and take a hands-on, “roll up your sleeves” approach
- Applicants must be currently authorized to work in the United States on a full-time basis.
Nice To Haves
- 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
- FDA/EMEA submission experience a plus
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, 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
- Works with line manager and/or Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
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What This Job Offers
Job Type
Full-time
Career Level
Director
