Statistical Programmer II

Job Location

275 Grove Street, Suite 101C, Newton, MA 02466 and position may telecommute from anywhere in the United States 5 days per week.

Statistical Programmer II

Use programming techniques to produce derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings in compliance with CDISC standards. Provide technical expertise for clinical trials and support programming activities related to analysis and reporting of clinical study data. Assist in project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Create define.xml files and reviewer guides for inclusion in regulatory submissions.

Use efficient programming techniques to quality control low‑medium complexity derived datasets, tables, figures, and data listings. Produce Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications. Assist in the production and quality control of derived dataset specifications and other process supporting documents and submission documentation. Implement statistical analysis plans (SAPs) by writing SAS code. Provide training and mentorship to staff and project teams.

Maintain all supporting documentation for studies in accordance with SOPs and guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs, guidelines, ICH‑GCP, and any other applicable local and international regulations, and participate in internal and external audits and regulatory inspections. Participate in process/quality improvement initiatives and work with P21 Enterprise version. Position may telecommute from anywhere in the United States 5 days per week.

• 5 progressive years of statistical programming experience and a Bachelor’s degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a related field.
• Five years of experience in developing and validating SAS programs for clinical trial data analysis, including data cleaning, data integration, and report generation.
• Experience creating and maintaining ADaM datasets in compliance with CDISC standards.
• Experience producing Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications.
• Experience implementing statistical analysis plans (SAPs) by writing SAS code.
• Experience performing quality control checks on SAS programs and outputs produced by other team members.
• Familiarity with standard SAS macros and tools, including Base, Stat, Macro, EG, Studio, Graph, ODS, and Report.
• Experience creating define.xml files and reviewer’s guides for inclusion in regulatory submissions and working with ICH‑GCP and 21 CFR Part 11.

Annual salary: $ - $132,400.

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.