Senior Statistical Lead

2 days ago


pushkar, India beBeeDataAnalyst Full time

Key ResponsibilitiesWe are seeking a seasoned professional to lead our statistical programming efforts.Data Management and Analysis: Develop, validate, and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures), and submission-ready outputs.Statistical Programming: Perform end-to-end statistical programming activities across all phases of Oncology clinical trials.Integrated Analysis: Support integrated analysis activities for ISS and/or ISE as part of regulatory submissions.Safety and Efficacy Analysis: Conduct safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.Programming Specifications: Develop edit checks, data review listings, and derive specifications aligned with study requirements.Collaboration: Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory teams to ensure timely and quality deliverables.Regulatory Compliance: Ensure compliance with CDISC standards, regulatory guidelines, and company SOPs.Process Optimization: Support automation, process optimization, and QC initiatives for continuous improvement.



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