Statistical Programmer

3 weeks ago

Vijayawada, India Astek Full time

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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