Principal Statistical Programmer

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

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 Masters degree in Management Information Systems Statistics or a related degree plus 2 years (or a Bachelors 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 and cite requisition number 00859 or apply at . This notice is subject to Parexel International LLCs employee referral program.

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Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.