Job Description Key Responsibilities
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Develop, validate, and maintain ADaM datasets , TLFs , and other analytical outputs for clinical trials. N
Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables. N
Contribute to ISS/ISE activities , including dataset integration, analysis, and documentation. N
Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery. N
Assist in regulatory submissions and RTQs , providing clear, traceable, and compliant programming outputs. N
Collaborate in an agile setting , participating in sprint meetings, planning, and continuous improvement discussions. N
Work with internal tools and platforms, including GSK-specific tools , following established standards and governance. N
Troubleshoot data/programming issues and propose process enhancements. N
Ensure adherence to CDISC standards, positive programming practices, and audit-ready documentation. N

n Required Skills & Qualifications
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Proficiency in R programming N
(Intermediate candidates with strong learning intent and ability to upskill quickly will also be considered.) N
Solid experience in SAS programming , especially in a clinical/biostatistics setting. N
Hands-on expertise in ADaM dataset development and TLF programming . N
Good understanding of CDISC standards and clinical trial data flow. N
Robust problem-solving skills, attention to detail, and ability to work in cross-functional teams. N

n Preferred Qualifications
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Advanced or Expert-level R Programming skills. N
Experience working on Oncology therapeutic area studies. N
Exposure to ISS/ISE, submission workflows, and regulatory interactions (e.G., RTQs). N
Practical understandingof agile ways of working (Scrum/Kanban). N
Prior experience using or supporting GSK tools and platforms N

📌 Statistical Programmer Ernakulam
🏢 Astek
📍 Ernakulam