Corcept Therapeutics
Associate Director, Statistical Programming
Redwood City, California, United States · Director · Full-time
Work authorization required$229k-$270kDetected 1 day ago
Data AnalysisData VisualizationStatisticsProject ManagementClinical TrialsFDA RegulatorySASCommunicationProblem Solving
About the role
- 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.
Responsibilities
- 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
- Validate data and results of statistical analyses generated by CROs
- Manage internal programming resources for study deliverables 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
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
- Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred
Nice to have
- Preferred Skills, Qualifications and Technical Proficiencies:
- Familiarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plus
- 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
Skills
- https://www.corcept.com/
- Corcept is an Equal Opportunity Employer
Compensation
- The pay range that the Company reasonably expects to pay for this headquarters-based position is $229,300 - $269,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Benefits
- Preferred Education and Experience:
Visa & Work Authorization
- Applicants must be currently authorized to work in the United States on a full-time basis.
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This listing is sourced directly from Corcept Therapeutics's careers page and normalized into a canonical job model.