Chief Clinical Data Analyst

6 days ago


madurai, India beBeeStatistical Full time

Senior Statistical LeadAbout the RoleDevelop, validate and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.Perform end-to-end statistical programming activities across all phases of Oncology clinical trials.Support integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Conduct safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.Develop edit checks, data review listings, and derive specifications aligned with study requirements.Prepare programming specifications, data mapping documents, and validation checks.Collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.Ensure compliance with CDISC standards, regulatory guidelines and company SOPs.Support automation, process optimization, and QC initiatives for continuous improvement.Required Skills & QualificationsBachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.7 years of hands-on experience in statistical programming with a strong focus on clinical trials (Oncology domain preferred).Expertise in creating safety and efficacy analysis outputs and submission packages.Strong working knowledge of data analysis and interpretation.Experience in writing documentation and technical reports.Strong problem-solving, analytical and communication skills.



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