Principal Statistical Programmer sought by Parexel International LLC reporting to headquarters in Newton, MA will provide statistical analysis & statistical support for clinical research questions on clinical trial data in an FDA 21 CFR Part 11 regulated environment.
Requirements:
- Master's degree in Management Information Systems, Statistics, or related degree, + 2 years (or a Bachelor's degree + 5 progressive years) of Statistical programming experience, including:
- Statistical analysis & statistical support for clinical research questions on clinical trial data in an FDA 21 CFR Part 11 regulated environment
- Analyzing Statistical Analysis Plans (SAPs)
- Statistical analysis & statistical programs using SAS
- Quality control on process & technical activities related to derived statistical dataset, table, listing, & figure programs in accordance with corporate quality standards, WSOPs/Guidelines, CIH-GCP, & international regulatory requirements within Phase I-IV clinical trials
- Evaluating & preparing project start-up activities, including project area set-up, creation of global programs, tracking spreadsheets, & required documentation
- Utilizing SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Set, Proc Step, & Functions to generate statistical reports, tables, & listings
- Building Structured CDISC, SDTM, ADAM statistical datasets for clinical studies
Will accept any suitable combination of education, training, or experience. Telecommuting permitted from anywhere within the US up to 5 days/week.
Application Instructions:
To apply, please send resume to openings@parexel.com & cite requisition number 00859 or apply at jobs.parexel.com.
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