Lead Technical Specialist

2 weeks ago


aligarh, India beBeeTechnical Full time

As a Senior Technical Lead, you will play a key role in the development and maintenance of SDTM/ADaM datasets, TLFs, and submission-ready outputs.About the RoleYou will be responsible for end-to-end statistical programming activities across all phases of Oncology clinical trials.Key ResponsibilitiesDevelop 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.RequirementsSkillfully develop, validate, and maintain SDTM/ADaM datasets, TLFs, 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.BenefitsThis position offers the opportunity to work on complex projects and collaborate with cross-functional teams.



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