Director, Statistical Programming

Role Summary

Director, Statistical Programming responsible for successful execution of study-level and compound-level deliverables across the drug development life cycle, leading department initiatives and ensuring consistent programming standards across compounds, including CDISC data flows.

Responsibilities

• Oversee all programming activities on assigned compounds to ensure high quality and timely deliverables to support Corcept’s portfolio
• Manage timelines, anticipate issues, and propose solutions
• Plan and conduct meetings and presentations related to compounds and deliverables; track project timelines
• Demonstrate deep knowledge of key statistical analyses and patient populations for compounds
• Collaborate cross-functionally
• Ensure department guidelines are followed and modeled for all deliverables, including development and validation of statistical programming deliverables
• Develop robust procedures for dataset development and delivery, including novel validation approaches (e.g., using R)
• Establish operational processes and standards for the statistical programming group, including templates for SDTM, ADaM, and TLFs
• Communicate timelines and goals to department head, peers, and team members; convey complex statistical programming concepts to other programmers
• Plan and conduct meetings to set expectations and timelines for deliverables
• Manage internal and external (CRO) programming resources to ensure on-time, high-quality delivery of analysis results
• Define scope and review progress to ensure deliverables meet timelines and quality
• Ensure appropriate skill sets are assigned to programming tasks
• Evaluate CDISC electronic data packages for completeness and submission readiness
• Stay current with regulatory CDISC and clinical programming standards
• Contribute to initiatives for a new programming environment to enable future regulatory review and data integration
• Contribute to development of SAS macros and tools for repeated use in analyses and best practices for macro development and validation
• Manage relationships with statistical programming vendors for timely delivery

Qualifications

• In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
• Thorough knowledge of CDISC SDTM and ADaM specifications and regulatory guidelines
• Knowledge of technical requirements for the statistical programming environment
• Experience with clinical trial design, data collection, endpoints, statistical methods, and displays in oncology, endocrine, and neurology is preferred
• Familiarity with data visualization tools (Spotfire, Tableau, RShiny) is a plus
• Ability to operate independently in unstructured situations
• Ability to communicate technical information to a non-technical audience
• Additional programming languages: Python, R

Education

• B.Sc./B.A. in Science, Statistics, Mathematics, Data Science, Engineering, or related field (MS preferred)
• 10+ years of experience in clinical trial development (late-stage preferred)
• FDA/EMEA submission experience and strong communication skills
• Project management experience for statistical programming projects in clinical development
• Experience managing CRO-delivered statistical programming projects
• Experience managing FTE and/or FSP
• Experience building centralized teams and/or implementing department-level software for data delivery or visualization