Senior Manager, Statistical Programming

Responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses. Responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department.

Essential Responsibilities:

• Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
• 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
• Review CRO generated Statistical Analyses Plans and specifications for data and output displays
• Validate data and results of statistical analyses generated by CROs
• Stay current with regulatory requirements on CDISC and clinical regulatory programming standards
• Utilize CDISC implementation guides and industry validation software to check compliance of CRO-generated define.xml and CDISC datasets (SEND, SDTM, and ADaM)
• Evaluate CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness.
• Consult internal audit team in assessing regulatory compliance of CROs with respect to dataset and program validation standards
• Participate in standards governance and developing biometric department operational processes.
• Work with Director of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
• Work with Director of Statistical Programming 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
• Research, suggest SAS software upgrades, and work with SAS Institute on SAS system maintenance.

Preferred Skills, Qualifications and Technical Proficiencies:

• Knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
• Knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidance
• Knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer’s guides (SDRG, ADRG)
• Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine 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:

• Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering or related field (MS preferred)
• 5+ years of experience in clinical trial development (late stage preferred)
• FDA/EMEA submission experience a plus
• Demonstrated ability for project management of statistical programming projects in clinical development
• Experience managing delivery of statistical programming projects by CROs
• Able to navigate uncertainty with creative problem solving
• Ability to take a hands-on, “roll up your sleeves” approach

The pay range that the Company reasonably expects to pay for this position is $185,000 - $205,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered. 

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

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