Head of Programme Management, Regulatory
2 weeks ago
Join to apply for the Director, Statistical Programming role at Corcept Therapeutics
Reporting to the Head of Statistical Programming, the Director, Statistical Programming is responsible for successful execution of study-level, compound-level deliverables and milestones over the drug development life cycle in addition to leading various initiatives for department improvements.
Oversee all programming activities on assigned compounds to ensure high quality and timely deliverables to support Corcepts growing portfolio.
Ensure department guidelines are followed and modeled for all deliverables, including the development and validation of statistical programming deliverables.
Help to grow robust procedures for dataset development and delivery, including developing novel approaches to the validation process (e.g., Contribute to establishing operational processes and standards for the statistical programming group, including templates for SDTM, ADaM, and TLFs specifications.
Manage internal and external (CRO) programming resources to ensure on-time and quality delivery of analysis results.
Evaluate CDISC electronic data packages for completeness and ensure submission readiness of study data packages per CDISC standards and FDA guidance.
Stay current with regulatory requirements on CDISC and clinical regulatory programming standards, including therapeutic area-specific standards.
Contribute to initiatives for a new programming environment to host clinical data to enabling future regulatory review and data integration across Corcept-sponsored clinical trials.
Contribute to the development of SAS macros and tools for repeated program use for exploratory and post-hoc analyses as well as best practices for macro development and validation.
Manage business relationships with statistical programming vendors for the successful and timely delivery of compound milestones.
In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS.
Thorough knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidelines.
In-depth knowledge of technical requirements for the statistical programming environment.
Knowledge of clinical trial design, data collection, endpoints, statistical methods, and standard data summary displays used in oncology, endocrine, and neurology therapeutic areas is preferred.
Familiarity with data visualization tools (e.g., Spotfire, Tableau, RShiny) is a plus.
Additional programming languages: Python, R, a plus.
in Science, Statistics, Mathematics, Data Science, Engineering, or related field (MS preferred).
~FDA/EMEA submission experience and demonstrated communication skills.
~ Demonstrated ability for project management of statistical programming projects in clinical development.
~ Experience managing the delivery of statistical programming projects by CROs.
~ Managing FTE and/or FSP.
~ SDTM, Safety) and/or successful implementation of department level software for data delivery, visualization, or other automated processes.
The pay range that the Company reasonably expects to pay for this headquarters-based position is $205,000 - $253,300; Applicants must be currently authorized to work in the United States on a full-time basis.
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