Full Name
Sara Cook
Hospital/Organisation/Company
IliaCook Statistical Consulting, LLC.
Speaker Bio
Dr. Sara Cook is a visionary executive leader with deep expertise in data governance, CMC Statistics, advanced analytics. She currently serves as the Senior Vice President of Data Governance and Data Management at Citi, and is the Founder and President of IliaCook Statistical Consulting, LLC. Throughout her career, Dr. Cook has built a proven track record of delivering innovative data strategies and collaborative solutions across highly regulated fields, including the biotechnology, pharmaceutical, vaccine, and cell/gene therapy industries.
Highly relevant to her focus on CMC data governance, Dr. Cook previously served as the Head and Director of the Center of Excellence for Data Science, Advanced Analytics, and CMC Statistics at Novavax. In this capacity, she established and chaired the enterprise data governance program, translating data challenges into pragmatic action plans encompassing people, processes, and technology. She provided broad, critical support across CMC Statistics and preclinical areas, strategically developing global process characterization strategies and Continued Process Verification (CPV) programs. Dr. Cook brings extensive hands-on experience in addressing complex regulatory CMC inquiries, utilizing Quality by Design (QbD) methodologies, and authoring technical responses for the FDA.
In her current executive role, Dr. Cook successfully operationalizes enterprise data governance frameworks by aligning domain-level processes with strict regulatory commitments. She actively enhances end-to-end data management by uplifting data catalogs and lineage, and by designing comprehensive controls to ensure data quality and compliance. Through her consulting practice, she continues to support clients in optimizing robust biomanufacturing processes, technology transfers, and analytical methods through advanced statistical data analysis.
Dr. Cook holds a Doctorate of Philosophy in Chemical Engineering from Lehigh University, alongside a Master of Science and an Honors Bachelor of Science in Chemical Engineering from Drexel University. She is a recognized thought leader who serves on the Industrial Advisory Board for Drexel University’s Department of Chemical Engineering. She is also a frequent invited speaker on the intersection of AI, advanced analytics, and biotechnology at prominent industry conferences, including the PDA and PDA/PQRI.
Highly relevant to her focus on CMC data governance, Dr. Cook previously served as the Head and Director of the Center of Excellence for Data Science, Advanced Analytics, and CMC Statistics at Novavax. In this capacity, she established and chaired the enterprise data governance program, translating data challenges into pragmatic action plans encompassing people, processes, and technology. She provided broad, critical support across CMC Statistics and preclinical areas, strategically developing global process characterization strategies and Continued Process Verification (CPV) programs. Dr. Cook brings extensive hands-on experience in addressing complex regulatory CMC inquiries, utilizing Quality by Design (QbD) methodologies, and authoring technical responses for the FDA.
In her current executive role, Dr. Cook successfully operationalizes enterprise data governance frameworks by aligning domain-level processes with strict regulatory commitments. She actively enhances end-to-end data management by uplifting data catalogs and lineage, and by designing comprehensive controls to ensure data quality and compliance. Through her consulting practice, she continues to support clients in optimizing robust biomanufacturing processes, technology transfers, and analytical methods through advanced statistical data analysis.
Dr. Cook holds a Doctorate of Philosophy in Chemical Engineering from Lehigh University, alongside a Master of Science and an Honors Bachelor of Science in Chemical Engineering from Drexel University. She is a recognized thought leader who serves on the Industrial Advisory Board for Drexel University’s Department of Chemical Engineering. She is also a frequent invited speaker on the intersection of AI, advanced analytics, and biotechnology at prominent industry conferences, including the PDA and PDA/PQRI.
