Principal Statistical Programmer

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.

Parexel 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. EEO Disclaimer 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world's life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare's most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™