Junfang June Li, Ph.D.
Principal Consultant
About
• Executive Biostatistician with extensive expertise in the biopharmaceutical industry, specializing in IND, NDA, and BLA submissions, approvals, and product commercialization. • Demonstrated a successful track record in securing regulatory approvals across the US, EU, and Japan, with effective and outcome-driven interactions with the FDA, EMA, and PMDA. • Proficient in designing optimized clinical trial protocols, conducting comprehensive statistical analyses, ensuring data integrity and regulatory compliance throughout the development lifecycle, and employing advanced statistical modeling to support labeling strategies for NDA/BLA approvals. • Experienced in leading, managing, and building cross-functional teams, with a robust background in regulatory strategy and internal management. • Extensive therapeutic expertise includes Oncology, Hepatology, Cardiovascular Diseases, Chronic Kidney Diseases, Neurosciences/CNS, Rare Diseases, Rheumatology, Allergy, Dermatology, Respiratory, and Infectious Diseases.
United States
Greater Boston
Biotechnology
International Management Experience, International Management, International Business Strategy, International Companies, International Account Management, Strategy, Life Sciences, Drug Development, U.S. Food and Drug Administration (FDA), Full Life Cycle Development, Regulatory Submissions, Analytics, Analytical Skills, SQL, Business Analysis, Management, Medical Affairs, Bayesian methods, Big Data Analytics, Modeling and Simulation
Experience

Principal Consultant
MedAlliance.LLC
Boston, Massachusetts, United States

Senior Director of Data Sciences
Mitsubishi Tanabe Pharma Development America
New Jersey, USA
Junfang June Li, Ph.D.'s Contact Information
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