Masters degree or foreign academic equivalent in Computer Science, Statistics, or a highly related field of study with at least three 3 years of related progressive experience in i developing SAS programs for creation and archiving of statistical datasets and summary statistical tables, graphs, reports, and appendices; ii developing and validating Analysis Data Models ADaM data sets following Clinical Data Interchange Standards Consortium CDISC standards and Tables, Listings and Figures TLF; and iii developing quality CRFs, databases, reports, publications, and regulatory submission utilizing experience with clinical trials and familiarity with expectations of regulatory agencies, FDA, EMEA, MPA and PMDA.
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