Parexel FSP USA
Location
Newton, MA | United States
Job description
Duties: Parexel International LLC seeks a Senior Principal Statistical Programmer based in Newton, MA to perform statistical analysis, statistical programming, and quality control of derived statistical data for clinical trials in FDA 21 CFR Part 11 regulated environment. Produce clinical trial statistical reports and integrated clinical reports for complex Phase I-III clinical studies. Write statistical programs to analyze clinical trial data. Produce derived statistical datasets and both simple and advanced statistical tables, figures, and data listings using efficient statistical programming and analysis techniques. Mentor and train junior statistical programmers. Assist in production of derived dataset specifications and process support documentation. Perform quality control of derived datasets, simple tables, and data listings from other departments. Apply FDA regulatory requirements to statistical analysis and methods. Provide SAS and technical training to internal clients. Create standard macros and statistical applications to improve efficiencies. Ensure compliance with WSOP guidelines and ICH-GCP guidelines and participate in audits and regulatory inspections. Apply regulatory requirements and industry standards for CDISC, 21 CFR 11, and electronic submissions. Build structured datasets for clinical studies. Position may telecommute from anywhere in the U.S. up to 5 days per week.
Requirements: Employer will accept Bachelor’s degree in Statistics, Mathematics, Pharmaceutical Science, or a related field and 5 progressive years of statistical programming experience. Experience must include 5 years of experience with each of the following:
FDA 21 CFR Part 11 regulations; ICH-GCP, CDISC, and WSOP guidelines; Phase I, II, and III clinical trials; SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Step, Proc Step, and Functions; generating reports, tables, and listings for statisticians; and building structured, CDISC, SDTM, or ADaM databases for clinical studies.
To apply, please send resume to [email protected] and cite requisition number 00948, or apply at jobs.parexel.com. This notice is subject to Parexel International LLC's employee referral program.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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