Clinical Programming Specialist
5 days ago
Statistical Programming LeadWe seek an accomplished Senior Statistical Programmer to support the full spectrum of clinical programming activities across multiple studies.Develop, validate, and maintain clinical trial datasets and outputs using SAS and R programming languages.Lead and deliver statistical programming tasks, encompassing:Creation and review of SDTM and ADaM specificationsDevelopment of SDTM and ADaM datasetsTLF (Tables, Listings, Figures) programmingPreparation of Define.xml and reviewer's guidesDevelopment, enhancement, and maintenance of macros to support study and project requirements.Work independently with minimal oversight, ensuring timely and high-quality results.The preferred qualifications include prior experience working in global teams, in-depth knowledge of CDISC standards, regulatory submission requirements, supporting FDA and PMDA submissions, and ability to manage multiple studies simultaneously and prioritize tasks effectively.Key Responsibilities:The Senior Statistical Programmer will be responsible for:Programming, validating, and maintaining clinical trial datasets and outputsLeading and delivering statistical programming tasksCreating and reviewing SDTM and ADaM specificationsDeveloping and enhancing macros to support study and project requirementsCollaborating with cross-functional teams to achieve study goalsAs a key member of our team, you will have the opportunity to work on complex clinical programming projects, develop your skills, and contribute to the success of our organization.Requirements:To be successful in this role, you will need:Strong technical proficiency in SAS and R programming languagesAbility to work independently with minimal oversightExcellent communication and collaboration skillsExperience working in global or geographically distributed teamsKnowledge of CDISC standards and regulatory submission requirementsAbility to manage multiple studies simultaneously and prioritize tasks effectivelyIf you are a motivated and experienced statistical programmer looking for a new challenge, please apply today.
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Senior Clinical Data Analyst
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Data Driven Programming Leadership Role
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Madurai, India Gentell Full timeCompany DescriptionGentell is a leading global provider of innovative, efficient, and affordable wound care solutions tailored to meet the individualized needs of patients in nursing homes, hospices, and hospitals. With clinical specialists across the United States and Canada, we offer expert recommendations and education to support proper use of wound care...
