Statistical Programmer/Analyst II

Statistical Programmer/Analyst II position at ClinChoice Inc., a contract research organization in Horsham, PA. The duties include: Generate Define-XML packages to support FDA submissions and ensure submission readiness of all deliverables (15%). Analyze data and report statistical results (15%). Independently use SAS to develop SDTM and ADaM specifications and datasets in compliance with study-specific Statistical Analysis Plans (SAPs) (10%).Perform data monitoring activities and communicate any data issues effectively with Data Management and project stakeholders(10%). Independently annotate CRFs (aCRF) and contribute to documentation, review, and quality control of datasets and outputs (10%). Perform data validation and edit checks and resolve issues to ensure data integrity, consistency, and compliance with regulatory and industry standards (15%). Program, validate, and maintain SAS code (including macros) to generate analysis datasets and Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions (25%). Position reports to ClinChoice Inc. office in Horsham, PA. May work from the Horsham, PA, office location or may telecommute/work from a home location in the U.S. A minimum of a Master's degree and 12 months of work experience is required.