Associate Director, Statistical Programming

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that, when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. As a member of the Statistical Programming team, 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 for 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 the Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study reports. 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 analysis results. Review and provide feedback on CRO-generated Statistical Analysis Plans and SDTM and ADaM specifications for domain and analysis dataset development, ensuring 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, ADaM, define.xmls and reviewer’s guides). Evaluate CDISC electronic data packages for completeness, regulatory standards compliance, and submission readiness. Participate in standards governance and develop biometric department operational processes as applicable. Work with the 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. Preferred Skills, Qualifications, and Technical Proficiencies In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, and 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 and 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) is 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 a related field (MS preferred). 10+ years of experience in clinical trial development (late stage preferred). FDA/EMEA submission experience is 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. Pay range: $229,300 – $269,800. 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. Corcept is an Equal Opportunity Employer. #J-18808-Ljbffr