Senior Manager, Statistical Programming Job

Responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses. Responsible for submission readiness of study data packages per CDISC (Clinical Data Interchange Standards Consortium) standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department. Review CRO (Clinical Research Organization) 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 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. 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. Establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets. 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.

Minimum Requirements:
Education: Master’s degree or foreign degree equivalent in Statistics, Mathematics, Computer Science, Computer Engineering or related field.
Experience: Two (2) years of experience in job offered, or Statistical Analyst, Clinical Statistician, or in a related occupation.

Annual salary: $187,251-$262,170/yr.

How to apply: Submit resume via email to [email protected]. Must reference Ref# SP-CP

Special Skills Requirements:
Academic training or work experience in the following:
1. SAS Base
2. Clinical Data Interchange Standards Consortium (CDISC); Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications
3. Knowledge of Clinical Trial Design
4. Create specifications for SAP Defined Analysis
5. Generate TFLs (Tables, Figures, and Listings) using statistical programming software
6. Statistical programming macros for development of TFLs
7. CRO (Contract Research Organization) data analysis