Statistical Data Analyst

7 days ago

coimbatore, India beBeeStatistician Full time

Job SummaryDevelop, 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.Key Responsibilities:Troubleshoot data/programming issues and propose process enhancements.Ensure adherence to CDISC standards, good programming practices and audit-ready documentation.Requirements and Qualifications4-14 years of Industrial experienceProficiency in R programmingIntermediate 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 is this role important?Opportunity to work on impactful Oncology research with global teams.Continuous learning and upskilling environment.Collaborative, agile work culture.Exposure to end-to-end statistical programming lifecycle and regulatory submissions.

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