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 environment , 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, good 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 environment. 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