Deputy General Manager, Statistical Programming

Job Summary

Leading a large team of programmers, the full-time Deputy General Manager, Statistical Programming will manage programming activities for complex studies and regulatory submissions in a remote/hybrid environment, ensuring timely and high-quality deliverables while adhering to CDISC standards.

Key responsibilities

• Manage and mentor programming team members, ensuring successful completion of programming activities
• Lead statistical programming for multiple studies, developing and maintaining programming documentation and specifications
• Oversee the creation of SAS programs for SDTM and ADaM datasets, contributing to regulatory submissions and addressing health authority requests

Required qualifications

• Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline
• 14+ years of programming experience in clinical trial data processing within the biotechnology, pharmaceutical, or CRO industry
• Proficiency in SAS programming, with demonstrated experience in SAP, SDTM, and ADaM specifications
• In-depth knowledge of pharmaceutical clinical development and regulatory submissions
• Prior experience in staff development, leadership, and project management