Job DescriptionKey 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

nRequired Skills & Qualifications
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- Proficiency in R programmingn
- (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

nPreferred 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 understanding of agile ways of working (Scrum/Kanban).n
- Prior experience using or supporting GSK tools and platformsn

📌 Statistical Programmer (Ernakulam)
🏢 Astek
📍 Ernakulam