Principal Statistical Programmer RTP, NC/USA
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COMPANY: United Therapeutics
POSITION:Principal Statistical Programmer
JOB DURATION: Full Time/ Permanent
LOCATION: Research Triangle Park, NC
DESCRIPTION: Position Overview The Principal Statistical Programmer will lead and support programming activities for assigned clinical trials. This individual will program and/or validate submission ready electronic datasets, tables, figures and listings.
POSTING EXPIRATION DATE: Until position is filled
REQUIRED SKILLS: • Bachelor’s degree or higher in a computing or science related field • 7+ year’s SAS programming experience within the Biotechnology and/or pharmaceutical industry including Clinical Research Organizations • Expert knowledge of CDISC terminology and architecture for both SDTM & ADaM • Able to develop programming tools to efficiently create study specific SDTM and ADaM data sets • Able to develop complex derived trial outcomes for ADaM sets • Able to develop and support SDTM safety data pools. • Proficient with SAS (procedures, functions, advanced macro language, advanced ODS, SAS/Graph) • Demonstrated understanding of regulatory submission requirements and processes
RESPONSIBILITIES: • Develop, validate, maintain and document statistical analysis for clinical trials outputs (TRF) on the basis of the Statistical Analysis Plan, and of other trial documents (Protocol, CRF, Data Management Plan) following standard operating procedures, working documents, and established Good Programming Practice • Ensure the quality of trial datasets (SDTM and ADaM), metadata, tables, figures, listings, and statistical output • Act as subject matter expert on CDISC standards within department
ADDITIONAL INFORMATION: • 4+ year’s experience with statistical programming aspects required for regulatory submission related to therapeutic drug development • Familiar with Python, R, C++ • Familiar with source code management concepts and application
CONTACT INFORMATION: Name: Glenda Adams