Principal Statistical Programmer

Job Summary

Leading statistical programming activities for multiple complex clinical trials, the full-time remote Principal Statistical Programmer will oversee the creation and delivery of CDISC-compliant datasets, statistical tables, and regulatory submissions while mentoring junior programmers and ensuring quality control across projects.

Key Responsibilities

• Serve as the Lead Statistical Programmer for Phase I-IV clinical trials, managing all programming deliverables from study startup to final reporting
• Architect and validate CDISC-compliant datasets and prepare electronic submission documentation for global regulatory filings
• Provide technical oversight for programming deliverables from external CRO partners, ensuring compliance with Jazz standards and regulatory guidelines

Required Qualifications

• Bachelor's, Master's, or Ph.D. in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related field
• Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry
• Expert-level proficiency in SAS and familiarity with R/Python in a validated clinical environment
• Demonstrated experience with CDISC SDTM and ADaM models and regulatory filing processes
• Proven track record as the primary study or program lead programmer for multiple clinical studies