Senior Statistical Programmer

ROLES and RESPONSIBILITIES:

• Perform statistical programming review of case report forms (CRFs), annotated CRFs, database structures, statistical analysis plan (SAP) project documentation such as Statistical Analysis Plan (SAP), mock shells, programming specifications and annotated CRFs
• Provide the statistical programming support for assigned studies, in both production and QC of analysis dataset specifications, analysis datasets, statistical analysis tables, data listings, figures, and statistical appendices
• Provide the status of assigned tasks to Study Lead Programmer and Project Manager
• Identify, communicate, and manage study-based risks and issues
• Maintain supporting documentation for studies in accordance with SOPs, Work Instructions (WI) to ensure traceability and regulatory compliance
• Contribute to development of Statistical Programming standards and processes to improve quality, efficiency, and effectiveness
• Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
• Adhere learning and develop knowledge on the latest in CDISC Therapeutic standards, GCP and applicable ICH guidelines