Current Openings

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