Key Responsibilities /n /n
Develop, validate, and maintain ADaM datasets, TLFs, and other analytical outputs for clinical trials.

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Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all programming deliverables.

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Contribute to ISS/ISE activities, including dataset integration, analysis, and documentation.

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Work closely with statisticians, data managers, and clinical teams to ensure timely and quality delivery.

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Assist in regulatory submissions and RTQs, providing transparent, traceable, and compliant programming outputs.

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Collaborate in an agile environment, participating in sprint meetings, planning, and continuous improvement discussions.

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Work with internal tools and platforms, including GSK-specific tools, following established standards and governance.

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Troubleshoot data/programming issues and propose process enhancements.

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Ensure adherence to CDISC standards, good programming practices, and audit-ready documentation.

/n /n Required Skills & Qualifications /n /n




Proficiency in R programming

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(Intermediate candidates with solid learning intent and ability to upskill quickly will also be considered.)

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Solid experience in SAS programming, especially in a clinical/biostatistics setting.

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Hands-on expertise in ADaM dataset development and TLF programming.

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Good understanding of CDISC standards and clinical trial data flow.

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Strong problem-solving skills, attention to detail, and ability to work in cross-functional teams.

/n /n Preferred Qualifications /n /n
Advanced or Expert-level R Programming skills.

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Experience working on Oncology therapeutic area studies.

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Exposure to ISS/ISE, submission workflows, and regulatory interactions (e.g., RTQs).

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Practical understanding of agile ways of working (Scrum/Kanban).

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Prior experience using or supporting GSK tools and platforms

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📌 Statistical Programmer Kochi (India)
🏢 Astek
📍 India