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 strong 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 .
Positive 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

📌 Statistical Programmer (Kochi)
🏢 Astek
📍 Kochi