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Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box



September 22, 2022

Access On-Demand Webinar Here

The role of biostatistics during a clinical study is often underestimated and viewed merely as a black box of providing statistical inputs at the end of a trial. However, partnering early and often with a Biostatistician on the design of your IVD clinical trial can help avoid costly mistakes, such as inadequate data collection, inefficient data pipelining and data cleaning. Join NAMSA for this webinar as we examine these critical areas, provide insight on how to prevent unnecessary delays and walk through two real-world case studies.

Attendees of this webinar can expect to gain a better understanding of:

  • The value of biostatistics
  • Best practices to minimize downstream time with data cleaning and speed up clinical trials results
    • Data from multiple instruments
    • Data from multiple sites/partners
    • Using the EDC to your benefit


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Paul Steven, MS

Principal Biostatistician, IVD

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).