Java programming [h1.location_city]
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Java programming • chicago il
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Director of Statistical Programming
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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