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System One Senior Statistical Programmer in Pittsburgh, Pennsylvania

System One seeks a Senior Statistical Programmer in Pittsburgh, PA to Create analysis datasets and programming specifications for the support of statistical evaluation of drug safety and efficacy. Use statistical procedures to analyze clinical raw data by reviewing CRF (Case Report Form) and perform SAS programming. Use raw data to create STDM (Study Data Tabulation Model) and ADaM (Analysis Data Model) data sets and reconcile data. Create tables and data listings for inclusion in clinical study reports and regulatory submissions and develop SAS macros. Provide accurate and timely creation of submission data sets and corresponding documentation to support electronic submission to regulatory authorities for marketing approval. Review integrated SAP as it contains different studies with different drug doses, patient inclusion/exclusion criteria, primary and secondary endpoints, and study durations and analysis. Prepare guide explaining data issues, derivation of computed variables, and explaining different statistical procedures followed. Establish, maintain, and perform quality control and produce documentation of study databases. Qualified applicant must have a Master’s Degree Bioengineering, Biomedical Engineering, or a foreign equivalent, and at least 2 years of experience performing the following duties: creating analysis datasets and programming specifications; creating table and listings for inclusion in clinical study reports and regulatory submissions; using statistical procedures to check and process raw data and generate tables and data listings; performing CRF, SDTM, and ADaM data reviews and publishing documents review; developing SAS macros. Telecommuting is permitted. Qualified applicants email resumes to Elizabeth Sitera at Work4SystemOne@gmail.com . No phone calls please.

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