Both sides of the review table
Sponsor-side leadership from IND/IDE through NDA/PMA and post-market, plus direct review experience inside FDA-CDRH. I write statistical deliverables with the reviewer in mind.
Behind this pageFixed-effect meta-analysis forest plot on the log hazard-ratio scale; box size is proportional to inverse-variance weight.
- 2024
Statistics Subject Matter Expert · FDA-CDRH
Reviewed statistical sections of IDE, PMA, and 510(k) submissions and Q-Sub SAPs, including AI/ML and SaMD devices across cardiovascular, oncology, ophthalmic, and neurological indications.
- 2007 – present
Independent Statistical Consultant · Device, pharma & biotech sponsors
Fractional biostatistician for cardiovascular device companies and drug developers: design, SAPs, SAS/R programming, EDC builds, and submission support.
- 2016 – 2023
Director, Data Science & Informatics · Resonea
Led all statistics and data science for a sleep diagnostics device company across feasibility and pivotal studies.
- 2014 – 2016
Senior Biostatistician · Abbott Electrophysiology
Biostatistics and programming for cardiac arrhythmia ablation device trials submitted to CDRH.
- 2012 – 2013
Senior Biostatistician · Amgen Global Safety
Safety surveillance for anti-inflammatory biologics in Crohn's disease, RA, psoriasis, and psoriatic arthritis using SDTM/ADaM data.
- 2007 – 2008
Director, Data & Statistics · Medtronic (Kyphon)
Directed biostatistics and data management for a spine device post-market program.
- 2003 – 2007
Senior Manager, Biometrics · CryoCor
Lead data manager and biostatistician on a successful PMA for cardiac cryoablation; presented to FDA advisory panels.
- 2001 – 2003
Senior Scientist / Biostatistician · Syrrx
Statistics for structural genomics and drug discovery, including an ML algorithm for ligand pose detection.
- 1996 – 1998
Senior Biostatistician · Ionis (Isis) Pharmaceuticals
Lead statistician and programmer on a successful antiviral NDA to FDA-CDER.
Methods, standards, and tools
Particular depth in cardiovascular devices, with work across oncology, inflammatory disease, ophthalmology, neurology, and sleep medicine.
Regulatory
- NDA, PMA, 510(k), IDE
- FDA CDRH & CDER interactions
- Q-Sub and deficiency responses
- AI/ML & SaMD statistics
- ISS / ISE development
Methods
- Mixed effects & repeated measures
- Survival analysis
- Algorithm development & ML
- Sample size & randomization
- Safety surveillance
Tools & standards
- SAS (Base, STAT, Macro, Graph)
- R (tidyverse, ggplot2, lme4)
- CDISC SDTM / ADaM
- PASS, nQuery
- Python, SQL