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Sr. Manager, Stat Programming

Job Description:

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


Responsibilities:

  • Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
  • Develop specifications, build and execute 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 Head of Biometrics to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
  • 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
  • Research, suggest SAS software upgrades, and work with SAS Institute on SAS system maintenance


Requirements:

  • B. 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


Preferred Skills, Qualifications, or Technical Proficiencies:

  • In depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
  • In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
  • 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, Tablo, RShiny) a plus
  • Ability to operate independently in unstructured situations
  • Ability to communicate technical information to a non-technical audience


If you are interested, please submit your resume by email to hr@corcept.com

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