Senior Statistical Programmer

3 weeks ago

Bengaluru, India ACL Digital Full time
Senior Statistical Programmer (6-8 years of exp)
LOOKING FOR IMMEDIATE JOINERS / SERVING NOTICE PERIOD
Location : CHENNAI / BANGALORE / HYDERABAD
Mode : Onsite / Hybrid
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

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