Clinical Programming Expert

2 weeks ago


kollam, India beBeeStatistical Full time

Senior Statistical ProgrammerWe are seeking an experienced Senior Statistical Programmer to support end-to-end clinical programming activities across multiple studies.This role requires strong technical proficiency, autonomy, and the ability to collaborate effectively within cross-functional and global teams.Program, validate, and maintain clinical trial datasets and outputs using SAS and R.Lead and execute the full spectrum of statistical programming deliverables, including:Creation and review of SDTM and ADaM specificationsDevelopment of SDTM and ADaM datasetsTLF (Tables, Listings, Figures) programmingPreparation of Define.xml and reviewer's guidesDevelop, enhance, and maintain macros to support study and project requirements.The successful candidate will have prior experience working in global or geographically distributed teams, in-depth knowledge of CDISC standards and regulatory submission requirements, and experience supporting FDA and PMDA submissions.



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