Biostatistics Expert
US Principal Consultant
Leonard is part of the US Regulatory Affairs team
providing biostatistical and clinical perspectives from a manufacturer’s point
of view having led and served on multiple successful product core teams.
The key expertise areas of Leonard
- Biostatistical support
- US FDA submissions, pre-submissions,
IDE, 510(k), PMA
- CE-Mark Technical File
- Product development life cycle
management
- Verification, validation and
optimization study designs and analyses
- Clinical operations
- Team management
Before Qserve
Leonard has over 35 years’ experience working in the IVD and medical device
industries. Working with small startups all the way to large multinational
companies. Some product areas include, immunoassay, flow cytometry, lateral
flow, PCR, array and next generation sequencing, peripheral vascular and drug
releasing pulmonary devices. He has worked with all levels of complexity from
CLIA waived products to companion diagnostic products. Leonard is experienced
at assessing whether or not there is sufficient evidence to support the product
claims.
He earned his B.S. in Biology (UCDavis), M.S. in Biology (CalPolySLO)
and M.S. in Biometry (Medical University of South Carolina).
Learn more about our services within Regulatory Affairs