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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Principal Statistical Programmer
Job ID R0000040258 Newton, MassachusettsParexel International LLC
Job Location: 275 Grove Street, Suite 101C, Newton, MA 02466 and telecommuting permitted from anywhere within the U.S. up to 5 days per week
Job Title: Principal Statistical Programmer
Duties: Parexel International LLC seeks a Principal Statistical Programmer in reporting to headquarters in Newton, Massachusetts to conduct statistical analysis. 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 datasets, table, listings, and figure programming in accordance with corporate quality standards, ICH-GCP, and 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 supporting statistical analysis documentation for studies in accordance with regulatory guidelines to ensure traceability and regulatory compliance. Support project teams in the resolution of statistical analysis and statistical programming-related problems. Telecommuting permitted from anywhere within the U.S. up to 5 days per week. Annual Salary: $142,911.20 - $207,400.
Requirements: Master’s degree in Pharmaceutical Science or a related field plus two years of statistical programming experience. Must have at least two years of experience in each of the following: (1) statistical analysis and statistical support for clinical research questions on clinical trial data in an FDA 21 CFR part 11 regulated environment; (2) analyzing Statistical Analysis Plans (SAPs); (3) statistical analysis and statistical programming using SAS; (4) performing quality control on process and technical activities related to derived statistical datasets, table, listings, and figure programming in accordance with corporate quality standards, ICH-GCP, and regulatory requirements within Phase I-IV clinical trials; (5) evaluating and preparing project start-up activities, including project area set-up, creation of global programs, tracking spreadsheets, and required documentation; (6) utilizing SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS Data Set, Proc Step, and Functions to generate statistical reports, tables, and listings; and (7) building structured CDISC, SDTM, and ADaM statistical datasets for clinical studies.
To apply, please send resume to openings@parexel.com and cite requisition number 00934 or apply at jobs.parexel.com. This position is subject to the company’s Employee Referral Program.
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