No 3rd party or sub-vendor candidates
• Computer programming using SAS including SAS Macro, SAS STAT, SAS GTL, SAS Base and other relevant components of SAS as applicable. Understanding of computer operating systems, word processors, document applications
• 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 CDISC 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 utilities
Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject 8+ years clinical research and development statistical programming experience using SAS
Strong SAS Programming skills
Extensive hands-on experience in CDISC 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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