Provide SAS (Statistical Analysis System) programming and analysis support for medical clinical trials. Develop SAS coding and table
templates for preparing, processing and analyzing clinical data. Generate SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets from raw data as per CDISC (Clinical Data Interchange Standards Consortium) standards. Create/validate adverse event AE xml file used to load adverse event data to U.S. and international databases. Prepare ADaM datasets and tables, figures and listings (TFL) for pharmaceutical industry publications. Use macros effectively to standardize programs and improve code efficiency. Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
BS Computer Science, or related (Statistics, Mathematics, Life Sciences), or equiv., plus 5 yrs. experience in a clinical development
environment. 5 yrs. must include:1) advanced SAS data manipulation, analysis and reporting skills; 2) thorough knowledge of CDISC standards; 3) familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data; 4) experience generating SDTM and AdAM data sets; and 5) familiarity using macros.