Principal Statistical Programmer

Parexel•Newton, MA

2d•$142,911 - $207,400•Remote

About The Position

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.

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.

Responsibilities

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.