Principal Statistical Programmer - Data Standards
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A Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of CDISC Standards, Sponsor Specific Standards, or PRA Standards. They will develop tools to increase the efficiency, timeliness and quality of deliverables for data collection, tabulation, analysis and reporting. They will also define, and collect metrics about the use of standards. They will participate in the development of training of the operational staff in the areas of their expertise.
- Develop, implement and maintain end-to-end data standards from data collection to regulatory submission.
- Function as the lead developer with responsibility in creating and maintaining libraries for use in designing, programming edit-check programs and custom reports.
- Leads in the enforcement and governance of library items.
- Develop and maintain training and reference materials related to standards topics.
- An undergraduate degree or international equivalent from an accredited institution is required.
- 5 to 8 years of experience in industry in a role demonstrating knowledge of standards used by biometrics.
- Expertise in edit check programming and programming related to data management activities is required.
- Working knowledge of CDISC standards for data collection (CDASH) and tabulation (SDTM) and Controlled Terminology required.
- Proficient in the programming of edit checks in Medidata RAVE or other comparable clinical data management systems.
- Experience programming custom functions and SAS based listings.
- Excellent communication skills with demonstrated leadership ability.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.