Senior Technical Lead

1 week ago

bikaner, India beBeeStatisticalProgrammingLead Full time

About This Role:We are seeking a skilled Statistical Programming Lead to develop, validate and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs.This role involves performing end-to-end statistical programming activities across all phases of Oncology clinical trials, including integrated analysis activities for ISS and/or ISE as part of regulatory submissions.The Statistical Programming Lead will conduct safety and efficacy analyses, including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs.Responsibilities include developing edit checks, data review listings, and deriving specifications aligned with study requirements, preparing programming specifications, data mapping documents, and validation checks.Collaboration with Biostatistics, Data Management, Medical Writing and Regulatory teams is essential to ensure timely and quality deliverables.Ensuring compliance with CDISC standards, regulatory guidelines and company SOPs is also critical.Additionally, the successful candidate will support automation, process optimization, and QC initiatives for continuous improvement.Requirements:A Bachelor's or Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline is required.7 years of hands-on experience in Statistical Programming within clinical trials, preferably in the Oncology domain.Strong working knowledge of ISS or ISE programming submissions is necessary.Expertise in creating safety and efficacy analysis outputs and submission packages is also essential.Experience in edit checks development, dataset specifications and derivation logic writing is required.Strong problem-solving, analytical and documentation skills are necessary.Ability to work independently along with effective stakeholder communication is also required.

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