Responsibilities :
- 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.
Requirements :
- 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.
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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. ...
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