Clinical Statistical Programmer - III - Katalyst Healthcares & Life Sciences
Iselin, NJ 08830
About the Job
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.
- 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.
- 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).
Source : Katalyst Healthcares & Life Sciences
