Senior/Principal Statistical Programmer SAS + R (Remote) Principal Statistical Programmer responsibilities include generating SDTM, ADaM specifications, datasets, reviewer's guide and define.Xml files for multiple studies;
developing SAS programsto generate datasets, complex listings, tables and graphs;
delivering high-qualitystatistical programming results;
overseeing CRO's statistical programming deliverables;
supporting preparation of clinical study reports, regulatory submissions and exploratory analyses;
understanding FDA regulations affecting reporting of clinical trial data;
contributing to the creation, maintenance and validation of standards for programming tools, outputs and macros;
developing CRFs, edit check specifications, and data validation plans;
providing review and/orauthor data