The Principal Statistical Programmer (“Programmer”) will have experience in all required areas of a Senior Statistical Programmer. The Principal Statistical Programmer is responsible for providing statistical programming services for assigned clinical trials. This includes acting as the lead programmer for assigned clinical trials.
Responsibilities
• Exceed expectations and responsibilities of a Senior Statistical Programmer
• Understand and implement CDISC and other regulatory standards
• Follow internal SAS programming conventions
• Serve as programming lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
• Coordinate and ensure the accuracy and completeness of activities for assigned support programmers
• Create and maintain project timelines
• Design, develop, document and validate tools and macros to improve quality and efficiency of processes
• Prepare and review programming specifications for SDTM, ADaM and other derived datasets
• Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
• Analysis datasets (SDTM, ADaM, other derived datasets)
• Tables, listings and figures
• xml/Reviewer’s Guide
• Integrated summaries
• Perform ad hoc analyses of current and legacy databases
• Review and provide input on case report form design
• Serve as a subject matter expert
• Train and mentor others in task execution
• Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
• Develop department training materials and deliver trainings to the team
• Drive/facilitate/actively engage in department initiatives
• Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs