biostatistician

Aerotek is partnered with a company in Houston, Texas in search of a Sr. Clinical SAS Programmer

Job Responsibilities:
* Provide SAS programming and validation support for clinical study reports (CSRs) and other types of statistical reports (for FDA and other health related agencies/organizations).
* Produce and validate SDTM and ADaM data sets/analysis files, and tables, listings, and figures (TLFs).
* Produce and validate Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE).
* Create SAS data sets from various database management systems (e.g., EDC) and PC file formats.
* Assist clinical statisticians in the development and review of statistical analysis plans (SAPs) and SAS programming specifications.
* Assist data management in development and SAS programming of edit specifications.
* Follow CTP SOPs to ensure compliance with Westat requirements, client (sponsor) requirements and FDA and ICH regulatory guidelines.
* Determine when SAS software upgrades and Hot Fixes are required for the Clinical SAS Programming Team and ensure SAS software is installed, maintained, and documented in a regulatory compliant manner.
* Develop SAS macro libraries to standardize routine analysis or implement new methods.
* Manage the Clinical SAS Programming Team, maintain standards for Clinical SAS programming activities, and guide/coach the Clinical SAS Programmers.