Paul Steven joined the NAMSA in 2021. Focused solely on In Vitro Diagnostics (IVDs), Paul has experience with companion diagnostics (CDx), oncology, infectious disease, women’s health, automated and manual quantitative polymerase chain reaction (qPCR), high resolution melting (HRM), enzyme-linked immunoassay (ELISA), lateral flow and next generation sequencing (NGS). He brings extensive experience in research and development (R&D) and consulting arena with a focus on early and late phase clinical trial reporting. Paul is an expert at helping Sponsors navigate the statistical complexity of their studies while providing necessary outputs for regulatory submissions.
He received his Bachelor of Science (BSc) in mathematics and statistics with first class honours and his Master of Science (MSc) in statistics at Lancaster University (Lancaster, UK).
- Developing statistical strategies, study designs and statistical analysis plans (SAPs)
- Providing analysis expertise
- Developing specialist study designs and statistical approaches to align with device development strategy, leading to new approaches being accepted by the FDA
- Extensive knowledge of IVD development and verification and validation (V&V) process, design control and quality control (QC) release for qualitative and quantitative assays
- Statistical lead for input into regulatory submissions: FDA Premarket Approval (PMA), 510(k) and pre-submissions
- Statistical training sessions for R&D scientists and cross-functional product development teams
- Supporting strategic clinical study design
- Collaborating with clinical research, regulatory and data management to prepare practical strategies resulting in global market approvals
- Interfacing with global regulatory agencies
- NGS CDx Oncology Clinical Bridging study SAP writing, statistical analysis and reporting
- Development of SAP and analysis of database specifications for clinical performance study used to support 510k and In Vitro Diagnostic Regulation (IVDR) approval for real-time polymerase chain reaction (RT-PCR) antimicrobial resistance (AMR) assays
- Statistical support and analysis for clinical performance protocol development for multiplex infectious disease Molecular Diagnostics (MDx) panel for laboratory developed test (LDT) with sepsis indications