Job Description

• Provide programming support for study deliverables as assigned, ensuring that timelines are met and expected quality is attained.
• Liaise with Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements.
• Create and validate SDTM and ADaM datasets and associated submission deliverables in compliance with published industry standards and project/study specific requirements.
• Create and validate TFL output in compliance with study specific requirements.
• Receive, import, and verify the structure of external data.
• Create and maintain supporting documentation.
• Demonstrable expertise in SAS analysis and reporting programming.
• Demonstrable expertise with CDISC CDASH, SDTM, ADaM, DEFINE-XML, and/or controlled terminology.
• Perform other duties as assigned.

Requirements:

• Minimum Education: B.S. or equivalent in computer science, mathematics, or life science.
• A minimum of 5 years of relevant clinical research programming experience, 3 years specifically in the pharmaceutical industry.
• Demonstrable experience/expertise in analysis and reporting of phase I-IV clinical trial data.
• Demonstrable experience/expertise using SAS/Base and SAS/Stat.
• Demonstrable experience/expertise using CDISC standards: CDASH, SDTM, ADaM, DEFINE-XML, Controlled Terminology.
• Demonstrable proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

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