Job Location: 275 Grove Street, Newton, MA 02466 and telecommuting permitted from anywhere within the U.S. up to 5 days per week

Job Title: Principal Statistical Programmer

Job Duties: The Principal Statistical Programmer at Parexel International LLC reporting to headquarters in Newton, Massachusetts will provide statistical analysis and statistical support for clinical research questions on clinical trial data in an FDA 21 CFR Part 11 regulated environment. Analyze Statistical Analysis Plans (SAPs). Perform statistical analysis and statistical programming using SAS. Perform quality control on process and technical activities related to derived statistical dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and other international regulatory requirements within Phase I-IV clinical trials. Evaluate and prepare project start-up activities, including project area set-up, creation of global programs, tracking spreadsheets, and required documentation. Participate in quality improvement initiatives for statistical programming and analysis. Develop and maintain knowledge of SAS and other relevant statistical analysis and statistical programming languages and processes within the GRO, Biostatistics, and medical arenas. Utilize SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Set, Proc Step, and Functions to generate statistical reports, tables, and listings. Build structured and CDISC standard, SDTM, and ADaM statistical datasets for clinical studies. Maintain all supporting statistical analysis documentation for studies in accordance with WSOPS/Guidelines to ensure traceability and regulatory compliance. Support project teams in the resolution of statistical analysis and statistical programming-related problems encountered in the conduct of their daily work. Telecommuting permitted from anywhere within the U.S. up to 5 days per week.

Minimum Requirements: Requires a Master’s degree in Management Information Systems, Statistics, or a related degree, plus 2 years (or a Bachelor’s degree plus 5 progressive years) of statistical programming experience, including: statistical analysis and 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 and statistical programming using SAS; quality control on process and technical activities related to derived statistical dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, CIH-GCP, and international regulatory requirements within Phase I-IV clinical trials; evaluating and preparing project start-up activities, including project area set-up, creation of global programs, tracking spreadsheets, and required documentation; utilizing SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Set, Proc Step, and Functions to generate statistical reports, tables, and listings; and building structured CDISC, SDTM, and ADaM statistical datasets for clinical studies. Will accept any suitable combination of education, training, or experience. 

To apply, please send resume to openings@parexel.com and cite requisition number 00859, or apply at jobs.parexel.com. This notice is subject to Parexel International LLC's employee referral program.