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 [email protected] 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.
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
