Director, Statistical Programming

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. They will ensure consistent programming standards across their compound(s), bringing creative solutions to improving and implementing various data flows to and from the Statistical Programming function including CDISC standards.

By working with and leading compound-level teams as well as successfully collaborating with key Biometric stakeholders and senior management teams, they will bring excellent business acumen, presentation, communication, and negotiation skills along with the ability to drive meaningful change across all levels of the Biometrics organization.

Responsibilities:

• Oversee all programming activities on assigned compounds to ensure high quality and timely deliverables to support Corcept’s growing portfolio including:
• Successful management of timelines and the ability to anticipate issues as well as propose solutions to alleviate them
• Effectively plan and execute meetings and presentations related to compound and/or deliverables, as well as track project timelines
• Deep knowledge of key statistical analyses and patient populations for compound(s)
• Work collaboratively cross-functionally
• 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., using R)
• Contribute to establishing operational processes and standards for the statistical programming group, including templates for SDTM, ADaM, and TLFs specifications
• Transparent communication with department head, peers, and team members of timelines and ability to meet compound or department goals. This includes:
• Effectively communicating the status and timeliness of key compound milestones
• Effectively communicates statistical programming concepts, including complex algorithms, to other statistical programmers
• Planning and conducting meetings with team members to set expectations and the timeline for deliverables
• Manage internal and external (CRO) programming resources to ensure on-time and quality delivery of analysis results. This includes:
• Defining scope and reviewing progress/activities so that deliverables are completed to project timelines and with high quality
• Successful management of resources, ensuring an appropriate skill set is assigned to the different programming tasks
• 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

Preferred Skills, Qualifications and Technical Proficiencies:

• 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
• Ability to operate independently in unstructured situations
• Ability to communicate technical information to a non-technical audience
• Additional programming languages: Python, R, a plus

Preferred Education and Experience:

• 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 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
• Extensive experience in developing and implementing centralized teams (i.e., 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; 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.