Director of Statistical Programming

Job Summary

A company is looking for a Director, Statistical Programming.

Key Responsibilities

• Lead and manage all activities within the Statistical Programming function, ensuring integration with other departments
• Provide technical leadership and strategic direction for regulatory submissions and health authority requests
• Manage, mentor, and develop team members while overseeing vendor relationships and enhancing standard operating procedures

Qualifications

• Master's degree in Biostatistics or a related field with a minimum of 10 years of relevant experience, or Bachelor's degree with 12+ years
• Deep understanding of FDA, EMA, and ICH regulations and guidelines
• Proven experience with regulatory submissions including BLAs and MAAs
• Strong organizational leadership skills with the ability to manage multiple priorities
• Demonstrated ability to mentor and inspire confidence across teams