Junfang June Li, Ph.D.

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.

Country

United States

City

Greater Boston

Industry

Biotechnology

Skill

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

MedAlliance.LLC

Principal Consultant

MedAlliance.LLC

2026-2 - Present · 8 mos

Boston, Massachusetts, United States

Lantheus

Vice President Biometrics and Data Sciences

Lantheus

LinkedIn
2024-10 - 2026-2 · 1 yr 5 mos
FDA

Senior Mathematical Statistician

FDA

LinkedIn
2023 - 2024 · 1 yr

Silver Spring, Maryland, USA

Magenta Therapeutics

Vice President of Biometrics

Magenta Therapeutics

LinkedIn
2022 - 2023 · 1 yr

Cambridge, Massachusetts, USA

Kyowa Kirin, Inc.- U.S.

Vice President of Biometrics

Kyowa Kirin, Inc.- U.S.

LinkedIn
2016 - 2022 · 6 yrs

Princeton, New Jersey, USA

Otsuka Pharmaceutical Companies (U.S.)

Vice President of Biostatistics

Otsuka Pharmaceutical Companies (U.S.)

LinkedIn
2013 - 2016 · 3 yrs

Princeton, New Jersey, USA

Mitsubishi Tanabe Pharma Development America

Senior Director of Data Sciences

Mitsubishi Tanabe Pharma Development America

2010 - 2013 · 3 yrs

New Jersey, USA

Sanofi

Director of Biostatistics

Sanofi

LinkedIn
2001 - 2010 · 9 yrs

New Jersey, USA

Procter & Gamble

International Manager

Procter & Gamble

LinkedIn
1994 - 2001 · 7 yrs

Cincinnati, Ohio, United States

Education

Colorado State University

Colorado State University

LinkedIn

Mathematics Statistics

Lanzhou University

Lanzhou University

LinkedIn

Mathematics

Junfang June Li, Ph.D.'s Contact Information

Email

******@***.com

Phone

(**) *** ****

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