Clinical Trials Data Specialist

4 days ago

lucknow, India beBeeStatistical Full time

Job Title: Statistical Analyst - Clinical Trials DeveloperThis role involves the development, validation, and maintenance of ADaM datasets and TLFs for clinical trials. The ideal candidate will have a solid understanding of CDISC standards and clinical trial data flow, as well as hands-on experience in ADaM dataset development and TLF programming.Responsibilities:• Develop, validate, and maintain ADaM datasets and TLFs for clinical trials.• Support Oncology studies by ensuring accuracy, consistency, and regulatory compliance in all deliverables.• Contribute to ISS/ISE activities, including dataset integration, analysis, and documentation.• Collaborate with cross-functional teams to ensure timely and quality delivery.• Troubleshoot data/programming issues and propose process enhancements.Requirements:• 4-14 years of Industrial experience.• Proficiency in R programming.• Solid experience in SAS programming, especially in a clinical/biostatistics environment.• 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 Qualifications:• Advanced 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).Benefits:• 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.About this Role:This is an exciting opportunity to join our team and contribute to the development of innovative solutions for clinical trials. If you are a motivated and detail-oriented individual with a passion for statistical programming, we encourage you to apply.

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