Director, Statistical Programming

Director, Statistical Programming

 Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity.

Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases. Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since its founding in 1998.

The Director, of Statistical Programming is responsible for building a high-performing programming team. They will develop strategic and consistent programming standards across all compounds, bringing creative solutions and implementing enterprise-wide technology platforms and data analytics. Responsible for exploring new technologies to enable successful FDA, EMEA submissions.

Build and lead global teams as well as successfully collaborate with executive-level 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 organization.

 Responsibilities:

• Build the statistical programming team to support Corcept’s growing portfolio
• Work with Biometrics leadership team to establish operational processes and standards for the statistical programming group including templates for SDTM, ADaM and TLFs specifications
• Mentor and oversee current employees in statistical programming for career growth
• Manage internal and external (CRO) programming resources to ensure on-time and quality delivery of analyses 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
• Consult internal audit team in assessing regulatory compliance of CROs with respect to dataset and program validation standards
• Work with Head of Biometrics to develop a structure and implement solutions for hosting clinical data and programs enabling future regulatory review and data integration across Corcept-sponsored clinical trials
• Manage the computing environment and statistical programming infrastructure for the Biometrics department including research and suggest SAS software upgrades, and work with SAS Institute on SAS system maintenance
• Coordinate the development of SAS macros and tools for repeated program use for exploratory and post-hoc analyses
• Manage business relationships and budgets with statistical programming vendors

Preferred Skills, Qualifications or Technical Proficiencies:

• In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
• Thorough knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
• 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 preferred
• Familiarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plus
• Ability to operate independently in unstructured situations
• Ability to communicate technical information to a non-technical audience

Preferred Education and Experience:

• B. Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering or related field (MS preferred)
• 12+ years of experience in clinical trial development (late-stage preferred)
• Extensive FDA/EMEA submission experience and demonstrated communication skills
• Demonstrated ability for project management of statistical programming projects in clinical development
• Experience managing delivery of statistical programming projects by CROs

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.