OVERVIEW:• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents• Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications• Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADaM datasets• Understand and execute department-, product- and study-level macros and utilities• Write, test and validate product- and study-level macros and utilitiesSkills: Computer programming using SAS including SAS Macro, SAS STAT, SAS GTL, SAS Base and other relevant components of SAS as applicableUnderstanding of computer operating systems, word processors, document applications Statistical Methodologies and Statistical SAS ProceduresKey Words/Education:Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject8+ years clinical research and development statistical programming experience using SASStrong SAS Programming skillsExtensive hands-on experience in CDSIC standards and datasets (SDTM, ADaM)Experience in FDA/EMEA trial submissions Drug Development (pre-, early, late and/or observational) in related industries or academic research
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