2025 Spring Issue
The Evolving Role of Statisticians in the Pharmaceutical Industry: Leveraging Advanced Statistical Analytics and Artificial Intelligence
Note from the Editor:
Welcome to the Spring Issue! This year's theme is "The Evolving Role of Statisticians in the Pharmaceutical Industry: Leveraging Advanced Statistical Analytics and Artificial Intelligence", and we hope that the articles we share will provide new perspectives and encourage everyone to further develop and grow in their role. In this issue we present various perspectives and invite you to a discussion around the current role of statisticians.
In addition, we share thought-provoking pieces about how to irritate regulators, recent advancements in the topic of covariates adjustment in modern clinical trials, as well as advice and tips on generative AI. Enjoy the fresh insights and inspirations this issue has to offer!
We would like to extend our sincere thanks to our esteemed contributors for their invaluable insights and contributions. Additionally, a big thank you to our ASA colleagues Megan Murphy and Olivia Brown for their tremendous support in production.
2025 ASA Biopharmaceutical Report Editorial Board:
Maria Kudela (Pfizer, Editor), Di Zhang (Teva, Associate Editor), Christie Watters (Novartis, Associate Editor), Charlotte Baidoo (BMS, Associate Editor), Francis Rogan (Merck, Associate Editor)
ASA Biopharmaceutical Section Chairs:
Ted Lystig(2024), Erik Bloomquist (2025), Steven Novick (2026)
ASA BIOP Chairs Transition Report
Ted Lystig (BIOP Chair, 2024) and Erik Bloomquist (BIOP Chair, 2025)
In Memoriam: Dr. Meijing Wu (1984-2024)
Yingwen Dong (Sanofi), Weili He (AbbVie), and Yuqian Shen (Sanofi)
Featured Articles on Theme
Evolution of Biopharmaceutical Statistics
Mark Rothmann* (FDA), Yun Wang* (FDA), James Travis* (FDA)
How to Irritate Regulators: A Primer
Janet Wittes (Florida Atlantic University)
Erik Bloomquist (Merck), Maria Kudela (Pfizer)
Generative Artificial Intelligence as Modern-Day Electricity – One Step at a Time
Hong Tian and Tony Guo (BeOne Medicines USA, Inc., formerly BeiGene USA, Inc.)
Vijay Yadav (Merck)
Leadership and Career Development
ML/AI Innovation in Regulatory: Interview with Andrea Manfrin
Di Zhang (Teva), Maria Kudela (Pfizer)
It is Never too Early to Think About Statistical Leadership
Richard C. Zink (JMP Statistical Discovery LLC)
Charlotte Baidoo (BMS)
Erik Bloomquist (Merck) and Maria Kudela (Pfizer)
Back to School? Judy Li on MBA Programs and the Future of Statisticians
Erik Bloomquist (Merck) and Maria Kudela (Pfizer)
Working Group and Conference Update
Beth Ann Griffin (RAND), Lane Burgette (RAND), Staci Hepler (Wake Forest University), Sarah Lotspeich (Wake Forest University), and Mousumi Banerjee (University of Michigan)
Jingyi Liu (Eli Lilly), Henrik Ravn (Novo Nordisk), Yun Wang (FDA), Ying Wei (Columbia), Thomas Liu (Amgen), Imola Fodor (Genentech), Melanie Wright (Novartis), Hiya Banerjee (Eli Lilly)
Biopharmaceutical Section Safety Working Group: Accomplishments and Recent Developments
Lothar Tremmel (CSL Behring), Jürgen Kübler (QSciCon), Tarek Hammad (Takeda)
ASA Biopharmaceutical Section Student Paper Awards
Francis Rogan (Merck)
Di Zhang (Teva)
Rajeshwari Sridhara (FDA), Olga Marchenko (Bayer), Qi Jiang (Pfizer), Elizabeth Barksdale (LUNGevity Foundation), Yiyi Chen (Pfizer), Marc Theoret (FDA)
Rajeshwari Sridhara (FDA), Olga Marchenko (Bayer), Qi Jiang (Pfizer), Elizabeth Barksdale (LUNGevity Foundation), Yiyi Chen (Pfizer), Marc Theoret (FDA)
Justine Rochon (Boehringer Ingelheim) on behalf of EFSPI
Recap: 2025 Biostatistics Symposium of Southern California (BSSC)
Nicole (Xiaoyun) Li (BeOne Medicines), Larry Shen (Pharmapace, Inc.), Gajanan Bhat (TORL BioTherapeutics), Lindsay Younis (Children’s Oncology Group), Thomas Lin, Jihao Zhou (BlossomHill Therapeutics, Inc.), Olga Korosteleva (California State University, Long Beach), Cathy Cai (Pharmapace, Inc.)