Statistical Programmer (Ernakulam)

Key Responsibilities Develop, validate, and maintain ADaM datasets , TLFs , and other analytical outputs for clinical trials. Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables. Contribute to ISS/ISE activities , including dataset integration, analysis, and documentation. Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery. Assist in regulatory submissions and RTQs , providing clear, traceable, and compliant programming outputs. Collaborate in an agile environment , participating in sprint meetings, planning, and continuous improvement discussions. Work with internal tools and platforms, including GSK-specific tools , following established standards and governance. Troubleshoot data/programming issues and propose process enhancements. Ensure adherence to CDISC standards, good programming practices, and audit-ready documentation. Required Skills & Qualifications Proficiency in R programming (Intermediate candidates with robust learning intent and ability to upskill quickly will also be considered.) Solid experience in SAS programming , especially in a clinical/biostatistics environment. Hands-on expertise in ADaM dataset development and TLF programming . Good understanding of CDISC standards and clinical trial data flow. Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams. Preferred Qualifications Advanced or Expert-level R Programming skills. Experience working on Oncology therapeutic area studies. Exposure to ISS/ISE , submission workflows, and regulatory interactions (e.g., RTQs). Practical understanding of agile ways of working (Scrum/Kanban). Prior experience using or supporting GSK tools and platforms Apply on Kit Job: kitjob.in/job/4nbteb