Go to Client Portal
NAMSA

Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box

About

Date/Time

Date(s) - September 22, 2022
10:00 AM - 11:00 AM CT

Register 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

 

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.

Speaker

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).