Job Description

Key Responsibilities

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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 clear, 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, positive programming practices, and audit-ready documentation.
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Required Skills & Qualifications

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Proficiency in R programming
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(Intermediate candidates with robust 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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Positive 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.
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Preferred Qualifications

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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
🏢 Astek
📍 Kochi