Lead Data Developer

2 weeks ago

bharatpur, India beBeeClinical Full time

Job Summary:This position involves developing, validating, and maintaining datasets for clinical trials. The role requires ensuring accuracy, consistency, and regulatory compliance in programming deliverables.Develop ADaM datasets, TLFs, and analytical outputs for clinical trials.Support Oncology studies by delivering accurate, consistent, and compliant programming outputs.Contribute to Integrated Summaries (ISS)/Integrated Safety/ Efficacy (ISE) activities, including dataset integration, analysis, and documentation.Collaborate with statisticians, data managers, and clinical teams for timely and quality delivery.Provide clear, traceable, and compliant programming outputs for regulatory submissions and RTQs.Work in an agile environment, participating in sprint meetings, planning, and continuous improvement discussions.Utilize internal tools and platforms, following established standards and governance.Troubleshoot data/programming issues and propose process enhancements.Ensure adherence to CDISC standards and good programming practices.Required Skills & QualificationsIndustrial experience: 4-14 years.R programming proficiency.Solid SAS programming experience 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.Practical understanding of agile ways of working (Scrum/Kanban).Prior experience using or supporting internal tools and platforms.

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