Senior Statistical Programmer Analyst - T

Penumbra seeks a Senior Statistical Programmer Analyst to develop analysis programs and manage clinical trial datasets under the direction of a Statistics Project Manager. The role involves creating and validating statistical outputs, ensuring regulatory compliance with CDISC standards, and mentoring junior programmers in a remote setting.

Responsibilities

• Develop algorithms and write SAS programs to create analysis datasets per specifications
• Generate and independently validate data listings, summary tables, and graphs
• Prepare clinical trial datasets and programs for regulatory submission
• Mentor less experienced statistical programmers and serve as CDISC subject matter expert
• Manage data warehouse and interact with statisticians, data managers, and regulatory staff

Requirements

• Bachelor's degree in Statistics, Computer Science, or related field
• 5+ years statistical programming experience; 3+ years clinical statistical programming in medical device, biotech, or pharma
• Proficiency with Base SAS, SAS/GRAPH, SAS/ODS, SAS/STAT, and SAS/SQL
• Knowledge of CDISC standards (CDASH, SDTM, ADaM) and FDA regulations
• Experience with clinical data management systems (Oracle InForm, RAVE)
• SAS Certified Base and/or Advanced Programmer certification preferred