Posted:2 weeks ago|
Platform:
On-site
Full Time
Perform statistical programming review of casereport forms (CRFs), annotated CRFs, database structures, statistical analysisplan (SAP) project documentation such as Statistical Analysis Plan (SAP), mockshells, programming specifications and annotated CRFs Provide the statistical programming support forassigned studies, in both production and QC of analysis dataset specifications,analysis datasets, statistical analysis tables, data listings, figures, andstatistical appendices Provide the status of assigned tasks to StudyLead Programmer and Project Manager Identify, communicate, and manage study-basedrisks and issues Maintain supporting documentation for studies inaccordance with SOPs, Work Instructions (WI) to ensure traceability andregulatory compliance Contribute to development of StatisticalProgramming standards and processes to improve quality, efficiency, andeffectiveness Ensure audit readiness and quality control forall assigned statistical programming deliverables as well as accuracy andreliability of statistical analysis results Adhere learning and develop knowledge on thelatest in CDISC Therapeutic standards, GCP and applicable ICH guidelines
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