General Summary:
The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. Serves as a project lead Statistical Programmer within designated clinical sub-team(s).
Key Duties and Responsibilities:
- Use advanced features of SAS, including interfacing with other software applications and operating system tools
- Perform quality control checks of SAS code and outputs produced by other Statistical Programmers
- Demonstrate in-depth knowledge of clinical development and medical data
- Solve complex clinical trial reporting problems; provide technical support and exercise judgment to ensure accurate, timely study tasks
- Collaborate with Statistical Programmers, Biostatisticians, Data Management, and other submission-related departments (often with Senior Management)
- Create files, documents, and analyses needed for eCTD electronic submissions, 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 submissions
- Participate in cross-functional project teams for SOPs, guidelines, process improvements, system validation/acquisition, customization, and integration of new tools
Knowledge and Skills:
- Proficiency in SAS (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH)
- Intermediate knowledge of CDISC standards and clinical trials
- Regulatory submission experience
- Effective written and verbal communication
Education and Experience:
- Bachelorβs degree in a scientific discipline
- Typically 5+ years (M.S. or above) or 8+ years (B.S.) in biotech, pharmaceuticals, or a Clinical Research Organization
Benefits/Compensation (as stated): Eligible for annual bonus and annual equity awards; some roles may be eligible for overtime pay.