Provides statistical programming support for the implementation of data models and the reporting of clinical trials (SDTM-focused).
• 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 transf
• Bachelor’s degree in a quantitative or scientific field required. Master’s preferred.
• Ideally, 5 to 10 years of experience in SDTM programming with knowledge of latest regulatory expectations
• Excellent written and oral communication skills required.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.