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Staff Profile

Dr Ayon Mukherjee

Senior Research Associate

Background

I am a biostatistician and statistical methodologist with over 13 years of academic and pharmaceutical industry experience, specialising in the development and application of innovative statistical methods for clinical trials and drug development. My research focuses on Bayesian methodology, adaptive and innovative trial designs, Response-Adaptive Randomization (RAR), and Covariate-Adjusted Response Adaptive (CARA) Designs, Dose Optimisation design methos (Project Optimus), Evidence synthesis and borrowing, Causal inference, and Estimand-based approaches to clinical trial design and analysis.


I have extensive experience working at the interface of statistical methodology, clinical development and regulatory science. Prior to joining Newcastle University, I held a senior statistical leadership role in the pharmaceutical industry, where I led statistical strategy and methodology in regulatory submissions across multiple therapeutic areas, including oncology, immunology and cardiometabolic health. This experience has given me a strong understanding of the practical, scientific and regulatory challenges involved in translating methodological innovation into clinical development.


My research aims to develop statistically rigorous and practically implementable methods that improve the efficiency, ethics and decision-making of clinical trials. I have particular interests in early-phase dose optimisation, adaptive designs, Bayesian evidence synthesis and borrowing, response-adaptive randomisation, time-to-event methodology, competing risks, and the integration of pharmacometric information into clinical trial design. I am also interested in the regulatory adoption of innovative statistical methodology and in strengthening the connection between methodological research and real-world clinical development.


At Newcastle University, I contribute to methodological research within the Biostatistics Research Group, while maintaining active collaborations with academic and industry researchers internationally.


Areas of expertise

  • Biostatistics
  • Clinical trials
  • Novel trial design
  • Estimands


Google Scholar : ‪Dr. Ayon Mukherjee, CStat‬ - ‪Google Scholar‬

Research

My research focuses on statistical methods for improved design and analysis of clinical trials. I am particularly interested in:

1) Adaptive designs for clinical trials;

2) Dose Optimization Design Methods for Early Phase Oncology Trials (Project Optimus);

3) Estimands and Causal Inference methods

4) Statistical Methods for Time-to-Event Outcome (eg: Competing Risk methods, Frailty Models, Non-proportional Hazards).

5) Bayesian Borrowing approaches in Clinical Trials

6) Bayesian design methods for confirmatory rare-disease trials.

7) Innovative Design Methods for Master Protocols

Publications