Statistical Programmer/Analyst Iii

Work at a contract research organization. This is a mid-level Statistical Programmer Analyst position that involves acting as a programming lead. The job duties for the Statistical Programmer/Analyst III position include: Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan (10%). Develop ADaM analysis data specifications for programming following CDISC standard (10%). Develop SDTM specifications for programming datasets following CDISC standard (5%). Implement statistical data analysis and communicate with statisticians for statistical input (10%). Lead regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities on vaccine, oncology, and pharmacokinetics studies (25%). Create and validate CSDRG/ADRG based on protocol and define package (10%). Independently develop SAS programs to create SDTM datasets (5%). Independently implement SAS programs to generate Define-XML package for FDA submission (10%). Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management (5%). Develop, debug, and maintain SAS programs and macros to create Tables, Listings, and Graphs for Clinical Study Report following CDISC, industry guidelines, and Statistical Analysis Plan (10%).

May work from the Fort Washington, PA, office location or may telecommute/work from a home location in the U.S.