About
About
Paul Steven
Program Lead Biostatistician · 13+ years across oncology, biomarker development and companion diagnostics.
I specialise in adaptive trial design for biomarker-driven oncology, with a focus on complex and non-standard study endpoints across clinical, translational, and device applications. I bring a strong biological and assay-level understanding — including mechanistic pathways, molecular diagnostics and translational biomarkers — to ensure statistical approaches are aligned with underlying science and program decision-making.
I actively contribute to scientific knowledge-sharing through publications, presentations, and analytical tools.
What I Work On
- Bayesian Adaptive Trial Design — dose escalation (BOIN), dose expansion (MATS), biomarker-driven trials (basket, adaptive enrichment)
- Translational & Non-Traditional Endpoints — PD, ctDNA, MRD, analytical device output across a range of indications
- Assay Development & Validation — statistical leadership for IVD and companion diagnostic programs
- Simulation Frameworks — dose-response, biomarker thresholds, and design operating characteristics
- Core Therapy Areas and Software - Oncology, Infectious Disease, Rare (including Opthalmology), IVDs. SAS, PASS, R (shiny), nQuery.
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Selected Publications & Writing
Timing of Bronchoscopy and Plasma Microbial Cell-Free DNA Sequencing in Immunocompromised Host Pneumonia Read on Open Forum Infectious Diseases →
Biomarker-Driven Clinical Trials in Oncology: Enrichment, Stratification, All-Comers & Basket Read on Precision for Medicine →
Treatment-Induced Viral Cure of Hepatitis C Virus-Infected Patients Involves a Dynamic Interplay among three Important Molecular Players in Lipid Homeostasis: Circulating microRNA (miR)-24, miR-223, and Proprotein Convertase Subtilisin/Kexin Type 9 Read on EBioMedicine →