ASA Biopharmaceutical Report | Substack

ASA Biopharmaceutical Report

A non-peer-reviewed journal under American Statistical Association (ASA) Biopharmaceutical Section

Launched 2 years ago

2026 Spring Issue

Statistics Reimagined for Discovery and Decision-Making

May 4•ASA Biopharmaceutical Report

2025 Winter Issue

The Evolving Role of Statisticians in the Pharmaceutical Industry: Leveraging Advanced Statistical Analytics and Artificial Intelligence

Dec 18, 2025•ASA Biopharmaceutical Report

Bridging Industry and Regulatory Perspectives: Statistical Frameworks for Clearer Drug Development and Review

Susan Mayo (FDA)

Apr 29•ASA Biopharmaceutical Report

openstatsware: Recent Highlights and Ongoing Work

Daniel Sabanés Bové (RCONIS), Alessandro Gasparini (Red Door Analytics), Ya Wang (Gilead Sciences)

Apr 29•ASA Biopharmaceutical Report

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Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Statistical Considerations for Interpreting Duration of Response in…

Rajeshwari Sridhara (FDA), Gautam Mehta (FDA), Olga Marchenko (Bayer), Brittany McKelvey (LUNGevity Foundation), Qi Jiang (Pfizer), Yiyi Chen (Pfizer…

Apr 29•ASA Biopharmaceutical Report

How Many Vials for Brazil? Efficiency+ Brings Statistical Innovation to Trial Operations

Fei Chen (Johnson & Johnson) on behalf of the Efficiency+ Scientific Working Group

Apr 27•ASA Biopharmaceutical Report

AI Finds Patterns. When Do They Become Evidence?

Jingyun Jia (UW-Madison), Ben Lengerich (UW-Madison)

Apr 27•ASA Biopharmaceutical Report

ASA Biopharmaceutical Report

A non-peer-reviewed journal under American Statistical Association (ASA) Biopharmaceutical Section