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:
Bachelors 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.
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