Katalyst Healthcares and Life Sciences
Responsibilities:
Design, code, and test SAS programs used to generate CDISC SDTM & ADaM domains and tables, listings & figures outputs. Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested. Validate CDISC SDTM and ADaM data sets by using Open-CDISC Validation Tool. Design, code and test SAS macro libraries to be used for development standardization. Create data definition documents for CDISC SDTM and ADaM datasets and other electronic submission components utilizing protocols, statistical analysis plans and table, listing & figure shells document. Quality control and validation of SAS programs. Conduct data edit checks to ensure the quality of source data. Review CRF annotations and database data. Interact with users and interpret their requirements. Manage programming timelines, schedules, and activities on specific programming tasks. Assist in maintaining compliance and in meeting CDISC requirements. Assist in gaining process efficiencies and standardization. Requirements:
Bachelor's degree in computer science/statistics or related field or equivalent related experience preferably in a pharmaceutical or clinical environment. 5+ years' experience in statistical programming for clinical trials. Expertise in SAS/BASE and SAS/GRAPH. Experienced using PROC REPORT, SAS/MACRO, SAS/STAT and ODS. 3+ years relevant SDTM, and ADaM experience required. Highly effective ability to anticipate problems and develop and implement solutions to projects. Adapts to changing conditions and reacts well under pressure. Takes initiative to learn and is self-directed. Excellent interpersonal skills. Highly organized and result oriented. Ability to work independently as well as in a team environment. Basic knowledge of Word and Excel.
Design, code, and test SAS programs used to generate CDISC SDTM & ADaM domains and tables, listings & figures outputs. Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested. Validate CDISC SDTM and ADaM data sets by using Open-CDISC Validation Tool. Design, code and test SAS macro libraries to be used for development standardization. Create data definition documents for CDISC SDTM and ADaM datasets and other electronic submission components utilizing protocols, statistical analysis plans and table, listing & figure shells document. Quality control and validation of SAS programs. Conduct data edit checks to ensure the quality of source data. Review CRF annotations and database data. Interact with users and interpret their requirements. Manage programming timelines, schedules, and activities on specific programming tasks. Assist in maintaining compliance and in meeting CDISC requirements. Assist in gaining process efficiencies and standardization. Requirements:
Bachelor's degree in computer science/statistics or related field or equivalent related experience preferably in a pharmaceutical or clinical environment. 5+ years' experience in statistical programming for clinical trials. Expertise in SAS/BASE and SAS/GRAPH. Experienced using PROC REPORT, SAS/MACRO, SAS/STAT and ODS. 3+ years relevant SDTM, and ADaM experience required. Highly effective ability to anticipate problems and develop and implement solutions to projects. Adapts to changing conditions and reacts well under pressure. Takes initiative to learn and is self-directed. Excellent interpersonal skills. Highly organized and result oriented. Ability to work independently as well as in a team environment. Basic knowledge of Word and Excel.