Clinical Statistical Programmer

Clinical Statistical Programmer

  |     |   No comment

Website Element Technologies Inc

Seeking qualified Clinical Statistical Programmer w/master’s in science or CS and 6 months of related work experience to Work collaboratively with Clinical Operations, Statisticians and Data Management for statistical data analysis and creating CDISC package. Use knowledge of clinical trial study design and electronic data submission requirements for NDA and provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.). Create SDTM and ADaM models according to CDISC standards, create tables, listings and graphs as well as integrated summary of safety (ISS) and integrated summary of efficacy (ISE) reports for submission to FDA. Create standard Macros and implement new tools/ software to minimize programming effort. Create macros for report generation and modifying company designated macros for producing statistical reports and data analysis. Create, validate and approve CDISC compliant datasets, statistical analysis result, define.xml and corresponding documentation for electronic submission to regulatory agencies. Create and maintain department SOPs related to clinical programming. Travel to an unanticipated worksite location may be required.

 

Aspiring Candidates can Mail Resume to:

Element Technologies, Inc.

15 Corporate Place South, Ste 209

Piscataway, NJ 08854.

Job Loc: Piscataway, NJ.

To apply for this job email your details to info@elementtechnologies.com