Statistical Programmer II
About The Position
Parexel International LLC seeks a Statistical Programmer II reporting to headquarters in Newton, Massachusetts to conduct statistical programming. 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.
Requirements
- Bachelor’s degree in Statistical Programming, Mathematics, Statistics, Data Analytics, Business Administration, or a related field plus 5 progressive years of statistical programming experience.
- Five years of experience in developing and validating SAS programs for clinical trial data analysis, including data cleaning, data integration, and report generation.
- Five years of experience in creating and maintaining Analysis Data Model (ADaM) datasets in compliance with CDISC standards.
- Five years of experience in producing Tables, Listings, and Figures (TLFs) for clinical study reports, regulatory submissions, and publications.
- Five years of experience in implementing statistical analysis plans (SAPs) by writing SAS code.
- Five years of experience in performing quality control checks on SAS programs and outputs produced by other team members.
- Five years of experience in maintaining, and utilizing standard SAS macros and tools, including Base, Stat, Macro, EG, Studio, Graph, ODS, and Report.
- Five years of experience in creating define.xml files and reviewer’s guides for inclusion in regulatory submissions.
- Five years of experience working with ICH-GCP and 21 CFR Part 11.
Responsibilities
- Conduct statistical programming.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
