Expert Oncology Clinical Trials Leader

3 days ago


salem, India beBeeStatistical Full time

Senior Statistical LeadAs a senior statistical lead, you will be responsible for the end-to-end statistical programming activities across all phases of Oncology clinical trials. This includes developing, validating, and maintaining SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.Develop specifications, data mapping documents, and validation checks aligned with study requirements.Collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables.Required Qualifications & Skills:Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline.7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred).Strong working knowledge of ISS or ISE programming submissions.Key Responsibilities:Ensure compliance with CDISC standards, regulatory guidelines, and SOPs.Support automation, process optimization, and QC initiatives for continuous improvement.



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