Associate Director of Statistical Programming

Job Summary

To support regulatory and scientific objectives, the remote full-time Associate Director of Statistical Programming will manage the production of analysis datasets and statistical outputs, collaborating with internal teams and external vendors to ensure high-quality deliverables.

Key responsibilities

• Collaborates with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
• Generates and oversees programming deliverables, including tables and listings for study reports and integrated summaries
• Identifies and leads strategic initiatives for the programming group while ensuring compliance with departmental procedures

Required qualifications

• BS degree in Biostatistics/Computer Science or equivalent with 10+ years of experience in pharma/biotech, or MS degree with 8+ years, or PhD with 3+ years
• Extensive hands-on experience with regulatory submissions and integrated analysis activities
• In-depth understanding of clinical programming processes and regulatory requirements relevant to statistical programming
• Proficiency in statistical programming using SAS software, including development and use of SAS Macros
• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM)