2025 Winter Issue
The Evolving Role of Statisticians in the Pharmaceutical Industry: Leveraging Advanced Statistical Analytics and Artificial Intelligence
Note from the Editor:
As 2025 comes to a close, we hope this year has brought you meaningful connections and moments to celebrate. Recent gatherings such as JSM and RISW united statisticians, data scientists, and quantitative researchers, sparking dynamic conversations on emerging trends and innovations.
In this Winter issue, we continue the conversation about the role of statisticians in the biopharmaceutical industry, offering plenty of engaging reads. Among them are an insightful piece from Margaret Gamalo on Systems Biostatistics: Making Speed in Drug Development Safe, and thoughtful reflections from Haoda Fu and Amy Xia on the roots of our profession and its evolving impact. You’ll also find practical guidance on leadership and career development, along with key takeaways from recent conferences. As we wrap up, I want to extend heartfelt thanks to all our contributors, readers, and the editorial team. Your insights and passion drive progress in biostatistics and quantitative science, and we look forward to continuing this journey with you in the year ahead. Wishing you a peaceful, restorative, and joy-filled holiday season!
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)
Featured Articles on Theme
Systems Biostatistics: Making Speed in Drug Development Safe
Margaret Gamalo (Pfizer)
Haoda Fu (Amgen), H. Amy Xia (Amgen)
Practical Considerations for Integrating AI/ML in Clinical Trials
Ye Li (FDA)
Unleashing AI-Generated Digital Twins to Deliver More Efficient Randomized Clinical Trials
Arman Sabbaghi (Santen Inc.)
How Regulatory Statisticians Can Adapt to New Challenges in the AI Era
Feiming Chen (FDA)
Natural Language Processing Meets FDA: My AI Adventure in the Post-Marketing Space
Yong Ma (FDA)
Leadership and Career Development
Celebrating Excellence: 2025 ASA Fellows and Their Impact on Statistical Science
Maria Kudela (Pfizer)
Survey Report on the Future of Nonclinical Statistics
Aili Cheng (Pfizer), Eve Pickering (Pfizer), Charles Tan (Pfizer)
Bold Moves: How an Early Pivot to Biotech Accelerated One Executive’s Rise
Emily Butler (ProKidney)
Advice for statisticians in clinical trials
Scott Evans (The George Washington University)
Working Group and Conference Update
JSM 2025 Biopharmaceutical Section: Innovation, Collaboration, and Community
Jianchang Lin (Takeda), Biopharmaceutical Section Program Chair, 2025
Recap of the 2025 Boston Pharmaceutical Statistics Symposium
Gautier Paux (Sanofi), Maria Kudela (Pfizer), Tu Xu (Novo Nordisk), Kush Kapur (argenx), Kristin Baltrusaitis (Harvard), Wenting Cheng (Biogen), Zhaoyang Teng (Astellas), Jianchang Lin (Takeda)
Paul Faya (Eli Lilly and Company), John Kolassa (Rutgers University)
Jie Chen (Taimei), Dror Rom (Prosoft Inc), Wenjin Wang (Pfizer Inc)
Rajeshwari Sridhara (FDA), Olga Marchenko (Bayer), Qi Jiang (Pfizer), Brittany Mckelvey (LUNGevity Foundation), Yiyi Chen (Pfizer), Gautam Mehta (FDA)
Rajeshwari Sridhara (OCE, FDA), Olga Marchenko (Bayer), Qi Jiang (Pfizer), Elizabeth Barksdale (LUNGevity Foundation), Yiyi Chen (Pfizer), Donna Rivera (FDA), Marc Theoret (FDA)
Ming-Hui Chen (University of Connecticut)
Recap: IABS 11th Annual Statistics Workshop
Jia Liu (Pfizer), José G. Ramírez (Kite Pharma, a Gilead Company), Ruojia Li (Bristol Myers Squibb)
ASA Biopharmaceutical Section Scholarship Award Winners – 2025
ASA Biopharmaceutical Section