The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than ...
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Provides statistical programming support for the implementation of data models and the reporting of clinical trials (SDTM-focused).
Responsibilities:
Demonstrates advanced knowledge of computer programming, statistical analysis systems (SAS), and other procedural languages.
Shows solid understanding biometrics procedures, workflows, and software systems.
Displays ability to manage extremely large datasets for statistical analysis and mathematical model creation.
Exhibits excellent written and oral communication skills.
Demonstrates a strong knowledge and understanding of analysis data structure standards (ADaM) and a good understanding of conversion data structure standards (SDTM)
Applies leadership skills in the coordination of analysis and reporting activities for statistical programming projects.
SDTM or Tabulation datasets creation and QC
aCRF creation
Creation of SDTM define.xml and Study Data Reviewers Guide (SDRG)
Validate datasets
Raw Data transfers
SDTM or Tabulation Data transfer
Qualifications:
Bachelor’s degree in a quantitative or scientific field required. Master’s preferred.
Ideally, 5-10 experience in SDTM programming with knowledge of latest regulatory expectations
Excellent written and oral communication skills required.
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