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Statistical Programmer
Statistical ProgrammerAstek • Ajit, Rajasthan, India
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Statistical Programmer

Statistical Programmer

Astek • Ajit, Rajasthan, India
2 days ago
Job description

Key ResponsibilitiesDevelop, 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 & Qualifications4-14 years of Industrial experienceProficiency 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 .Good 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 QualificationsAdvanced 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 .Why Join Us?Opportunity to work on impactful Oncology research with global teamsContinuous learning and upskilling environmentCollaborative, agile work cultureExposure to end-to-end statistical programming lifecycle and regulatory submissions

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Statistical Programmer • Ajit, Rajasthan, India

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