Principal Programmer, Statistical Programming
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Job Description
Principal Statistical Programmer leading SAS clinical-trial reporting and eCTD submissions at global biotechnology company Vertex. Supporting clinical teams, CDISC compliance, quality control, and regulatory submissions.
Responsibilities:
- Work with management to delegate tasks appropriately and track progress
- Provide expert technical support to team members
- Serve as project lead Statistical Programmer on clinical sub-teams
- Use advanced SAS features, including interfaces with software applications and operating system tools
- Perform quality control checks of SAS code and output produced by other Statistical Programmers
- Solve complex clinical trial reporting problems
- Support daily operations and ensure study tasks are completed accurately and timely
- Engage with Statistical Programmers, Biostatisticians, Data Management, and other departments, often at Senior Management levels
- Create files, documents, and analyses required for electronic submissions in eCTD format, including ISS/ISE
- Provide leadership for 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 working on SOPs, guidelines, process improvements, system validation and acquisition, and implementation and integration of tools and technologies
Requirements:
- Bachelor’s degree in a scientific discipline
- Typically 5+ years of work experience for M.S. or above, or 8+ years for B.S.
- Work experience in biotech, pharmaceuticals, or a clinical research organization
- Proficiency in SAS language, procedures, and functions commonly used in clinical trial reporting
- Proficiency in SAS Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH
- Intermediate knowledge of CDISC standards
- Intermediate knowledge of clinical trials
- Regulatory submission experience
- Effective written and verbal communication skills
- Knowledge of clinical development and medical data
- Experience with eCTD submissions, including ISS/ISE
- Knowledge of Vertex SOPs and FDA/ICH/GCP regulations
Benefits:
- Annual bonus eligibility
- Annual equity awards
- Overtime pay eligibility in accordance with federal and state requirements
- Medical benefits
- Dental benefits
- Vision benefits
- Generous paid time off
- Week-long company shutdown in the Summer and the Winter
- Educational assistance programs including student loan repayment
- Commuting subsidy
- Matching charitable donations
- 401(k)
- Flexible work options through Remote-Eligible Flex Designation
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