Overview
On Site
Full Time
Skills
Quality Control
SAS
Editing
Database
Regulatory Compliance
CDISC
Computer Science
Statistics
Pharmaceutics
Clinical Trials
SAS/BASE
SAS/GRAPH
Reporting
SAS/MACROS
SAS/STAT
ODS
SDTM
Management
Organized
Microsoft Excel
Job Details
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.
- 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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