Lead Statistical Programmer

ogrammer

Location: 275 Grove Street, Suite 101C, Newton, MA 02466. Telecommuting permitted from anywhere within the U.S. up to 5 days per week.

Key Responsibilities:
• Conduct comprehensive statistical analysis to support clinical research considering FDA 21 CFR Part 11 regulations.
• Analyze and develop Statistical Analysis Plans (SAPs) to guide study protocols.
• Utilize SAS for statistical programming and analysis ensuring quality control on derived statistical datasets, tables, listings, and figures, abiding by ICH-GCP and corporate quality standards.
• Prepare and evaluate project start-up activities, including project area setup, creation of global programs, and necessary documentation.
• Engage in quality improvement initiatives within statistical programming and analysis.
• Maintain up-to-date knowledge of relevant statistical programming languages and processes in the biostatistics and medical fields.
• Employ SAS tools such as SAS/BASE, SAS/STAT, SAS/SQL, and SAS/MACRO to produce high-quality statistical reports and datasets.
• Build structured and CDISC-compliant SDTM and ADaM datasets to support clinical studies.
• Document statistical analysis processes to ensure transparency and compliance with regulatory standards.
• Assist project teams in resolving statistical programming challenges.

Required Qualifications:
• Master's degree in Pharmaceutical Science or related field.
• Minimum of two years experience in statistical programming and analysis:
• Experience in FDA 21 CFR Part 11 regulated environments.
• Proficiency in analyzing Statistical Analysis Plans.
• Expertise in SAS programming.
• Quality control experience related to statistical datasets and reporting.
• Skills in project startup evaluations and setup.
• Familiarity with CDISC standards, specifically SDTM and ADaM datasets.

If you are passionate about statistical programming and wish to contribute to improving patient health, apply today by sending your resume to [email protected], referencing requisition number 00934. You can also visit our jobs portal for more information. We look forward to finding the right talent for our team!

EEO Disclaimer:

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