Principal Statistical Programmer
Vertex Pharmaceuticals
3 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. Acts as project lead Statistical Programmer for designated clinical sub-team(s).
Key Duties And Responsibilities:
- Work regularly with advanced features of SAS (including interfacing with other software and operating system tools)
- Perform quality control checks of SAS code and output produced by other Statistical Programmers
- Demonstrate in-depth knowledge of clinical development and medical data
- Solve complex clinical trial reporting problems; provide technical proficiency and judgment to support daily operations and ensure accurate, timely study task completion
- Collaborate across functions (Statistical Programmers, Biostatisticians, Data Management, and other submission-related departments), often at Senior Management levels
- Create files, documents, and analyses needed for electronic submissions in eCTD format, including ISS/ISE
- Provide leadership to ensure compliance with Vertex SOPs and FDA/ICH/GCP regulations
- Create, review, and approve documentation supporting data analysis, reporting, and CDISC data submission
- Participate in cross-functional project management teams for SOPs, guidelines, process improvements, system validation, and integration of new tools/technologies
Knowledge And Skills:
- Proficiency in SAS (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH)
- Intermediate knowledge of CDISC standards
- Intermediate knowledge of clinical trials
- Regulatory submission experience
- Effective written and verbal communication
Education And Experience:
- Bachelor’s degree in a scientific discipline
- Typically 5+ years (M.S. or above) or 8+ years (B.S.) in biotech, pharmaceuticals, or Clinical Research Organization
Application:
- N/A
The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. Acts as project lead Statistical Programmer for designated clinical sub-team(s).
Key Duties And Responsibilities:
- Work regularly with advanced features of SAS (including interfacing with other software and operating system tools)
- Perform quality control checks of SAS code and output produced by other Statistical Programmers
- Demonstrate in-depth knowledge of clinical development and medical data
- Solve complex clinical trial reporting problems; provide technical proficiency and judgment to support daily operations and ensure accurate, timely study task completion
- Collaborate across functions (Statistical Programmers, Biostatisticians, Data Management, and other submission-related departments), often at Senior Management levels
- Create files, documents, and analyses needed for electronic submissions in eCTD format, including ISS/ISE
- Provide leadership to ensure compliance with Vertex SOPs and FDA/ICH/GCP regulations
- Create, review, and approve documentation supporting data analysis, reporting, and CDISC data submission
- Participate in cross-functional project management teams for SOPs, guidelines, process improvements, system validation, and integration of new tools/technologies
Knowledge And Skills:
- Proficiency in SAS (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH)
- Intermediate knowledge of CDISC standards
- Intermediate knowledge of clinical trials
- Regulatory submission experience
- Effective written and verbal communication
Education And Experience:
- Bachelor’s degree in a scientific discipline
- Typically 5+ years (M.S. or above) or 8+ years (B.S.) in biotech, pharmaceuticals, or Clinical Research Organization
Application:
- N/A