Applies industry and regulatory standards to create and maintain standardized databases for clinical trial data.

• Programs statistical analyses (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis systems (i.e. SAS®).
• Ensures the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to specifications for analysis datasets.
• Performs quality review of analysis dataset and TFL programs developed by other programmers and biostatisticians.
• Verifies that statistical analysis system programs and associated documentation are archived prior to the creation of final output.
• Develops new processes and  ensures all process improvements are implemented.
• Takes a lead role in the review of statistical analyses plans and provides essential feedback.
• Collaborates with other team members to develop quality reports, publications, and regulatory submissions.
• Maintains libraries of documented and validated programs, macros, and procedures which can be reused to aid in DMC programming efficiency.
• Serves as the chief mentor to other DMC programmers.
• Demonstrates expertise in industry programming standards.
• Contributes to DMC unit initiatives.

• Bachelor’s degree in a quantitative or scientific field required. 
• Minimum of 5 years of statistical programming experience desired. 
• Knowledge of SDTM, ADaM, and TFL programming required. 
• Experience with DMC is desired. Must have a thorough understanding of data. Expertise in unblinding the data is desired. 
• CRO or pharma experience is desired. 
• Prior experience mentoring more junior level team members is desired. 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.