Principal Statistical Programmer (Project Lead Statistical Programmer)
General Summary:
- Work with management to delegate tasks, track progress, and provide expert technical support. Designated member of clinical sub-teams as project lead Statistical Programmer.
Key Duties and Responsibilities:
- Use advanced SAS features (including interfacing with other software/applications and OS tools).
- Perform quality control on SAS code and outputs from other Statistical Programmers.
- Apply in-depth knowledge of clinical development and medical data.
- Solve complex clinical trial reporting problems; support daily operations with sound judgment.
- Partner cross-functionally with Statistical Programmers, Biostatisticians, Data Management, and other submission/data-related teams.
- Create eCTD submission files/documents/analyses, including ISS/ISE.
- Lead to ensure compliance with Vertex SOPs and FDA/ICH/GCP regulations.
- Create/review/approve documentation for data analysis, reporting, and CDISC data submission.
- Participate in cross-functional teams for SOPs, guidelines, process improvements, system validation/acquisition, and tool integration.
Knowledge and Skills:
- Proficiency in SAS (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH).
- Intermediate CDISC standards and clinical trials knowledge.
- Regulatory submission experience.
- Strong 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/pharma/CRO.
Pay Range:
- $149,200β$223,800; eligible for annual bonus and annual equity awards.