Clinical Statistical Programmer
Website Element Technologies Inc
Seeking qualified Clinical Statistical Programmer 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.
- Bachelor’s in Pharmacy & Information Systems and 24 months of related work experience as a Clinical SAS Programmer.
Submit résumé to HR, Element Technologies Inc., 15 Corporate Place South, Suite 209, Piscataway, NJ 08854.
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