Director of Statistical Programming

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