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Title:Senior Statistical Programmers
Salary:Commensurate with experience
Experience:1+
Location:US - Various

Description:

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 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.

 

Send Resume and Cover Letter to:

Mr. Ted Phillips
Professional Resources, Inc.
4 Daniels Farm Road, Suite 325
Trumbull, CT 06611


Responsibilities:
  • 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 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.

Requirements:

MS degree in Computer Engineering, Statistics or related field + 1 year of industry experience. 

Various locations in the U.S. per client assignment.

 

Send Resume and Cover Letter to:

Mr. Ted Phillips
Professional Resources, Inc.
4 Daniels Farm Road, Suite 325
Trumbull, CT 06611

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