Job Description

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.

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