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Title:Principal Statistical Programmer
Salary:Commensurate with experience
Location:US - Various


Develop SAS programs & datasets.

  • Develop SAS (Statistical Analysis Software) programs to analyze and report the data generated from clinical trials, quality and improvement initiatives and various ad-hoc analytical studies. 
  • Develop programs and provide mapping specifications based on study design to create datasets and define data definitions and metadata. 
  • Check the conformance of SDTM datasets against CDISC standards. 
  • Provide submission preparation and QC support for dataset section of eCTD backbone and to ensure submission readiness. 
  • Write user-defined, general purpose SAS MACROS. 
  • Generate programs to validate output reports, assist in the specification, development and validation of standardized modules, reports, and tables for FDA and international regulatory submissions. 
  • Customize statistical data output into reports, graphs, tables and listings utilizing up-to-date SAS PROCEDURES and tools in both UNIX and Windows environments. 
  • Write SAS programs to develop data summaries to analyze & generate tables and graphs, perform model selections and create front-end windows. 
  • Program for ISS/ISE and prepare analysis datasets. 
  • Program and document eSubmission and NDA filings.

MS degree in Computer Science or Statistics or related field with 1 year of industry experience.

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