Clinical Trials Data Analyst
2 weeks ago
Key ResponsibilitiesDevelop, validate and maintain ADaM datasets, TLFs, and other analytical outputs for clinical trials.Ensure accuracy, consistency and regulatory compliance in all programming deliverables for Oncology studies.Contribute to ISS/ISE activities including dataset integration, analysis and documentation.Collaborate closely with statisticians, data managers and clinical teams to ensure timely and quality delivery.Support regulatory submissions and RTQs by providing clear, traceable and compliant programming outputs.Participate in agile environment activities such as 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.Adhere to CDISC standards, good programming practices and audit-ready documentation.Required Skills & Qualifications4-14 years of Industrial experience.Proficiency in R programming language.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.BenefitsOpportunity 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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