Senior Statistical Programmer

3 days ago


Bengaluru, Karnataka, India ACL Digital Full time

Senior Statistical Programmer (6-8 years of exp)LOOKING FOR IMMEDIATE JOINERS / SERVING NOTICE PERIODLocation : CHENNAI / BANGALORE / HYDERABADMode : Onsite / HybridROLES 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 CRFsProvide 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 appendicesProvide the status of assigned tasks to Study Lead Programmer and Project ManagerIdentify, communicate, and manage study-based risks and issuesMaintain supporting documentation for studies in accordance with SOPs, Work Instructions (WI) to ensure traceability and regulatory complianceContribute to development of Statistical Programming standards and processes to improve quality, efficiency, and effectivenessEnsure audit readiness and quality control for all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis resultsAdhere learning and develop knowledge on the latest in CDISC Therapeutic standards, GCP and applicable ICH guidelines



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