Principal Statistical Programmer - Remote

Overview

As a Principal Statistical Programmer, you will support, lead, and provide oversight to SAS programming efforts for various projects and studies, ensuring the development, testing, maintenance, validation, and documentation of SAS programs to meet project needs.

In Short

• Review CRFs and create specifications for SDTM and ADaM datasets.
• Oversee generation of blank CRFs and define.xml files.
• Generate datasets, tables, listings, and figures for clinical trials.
• Provide programming support for regulatory and ad-hoc analyses.
• Perform quality control for SAS programs and study documents.
• Interact with clients and lead statistical programming efforts.
• Prepare reports for Data Monitoring Committees.
• Assist in training new hires and provide ongoing mentorship.
• Lead the development and maintenance of departmental procedures.
• Program and document global utility programs according to standards.

Requirements

• Bachelor's degree in Statistics, Mathematics, or related field.
• 8+ years of SAS programming experience in the Biotech or clinical trials industry.
• Knowledge of ICH guidelines and FDA regulations.
• Broad programming experience supporting clinical trials.
• SAS Certified Advanced Programmer preferred.
• Experience with Oncology and Rare Diseases is a plus.

Benefits

• Flexible working environment.
• Opportunities for professional development.
• Collaborative team culture.
• Comprehensive health benefits.
• Supportive management and mentorship.