Clinical Statistical Programmer - III

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.

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).