Pelkey Biostatistics Schedule a scoping call
Fractional Biostatistician · Clinical Data Scientist

Regulatory-grade statistics, without the full-time hire.

William L. (Bill) Pelkey, Ph.D., works with medical device and pharmaceutical sponsors on a fractional or project basis: SAPs, CSRs, TFLs, and submission support for IDE, PMA, 510(k), and NDA programs. Former FDA-CDRH statistics reviewer, with 25+ years on the sponsor side.

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Freedom From Atrial Fibrillation Recurrence, 12 Months Kaplan-Meier estimate
100 90 80 70 60 50 Free from recurrence, % Device 78.4% Control 57.5% 0 3 6 9 12 Months since procedure Number at risk Device 150 138 127 118 108 Control 75 64 55 48 41
Illustrative data, 2:1 randomization. HR 0.48 (95% CI 0.30–0.77); log-rank p = 0.002. Tick marks show censored patients. Censoring rules, the analysis population, and the test all belong in the SAP before the first patient is enrolled.
25+ yearsPharma, biotech, and medical device
FDA-CDRHFormer Statistics SME reviewer
NDA & PMALead statistician on successful submissions
SAS & R20+ years of SAS; daily R
Contents

How I can help

Small and mid-size sponsors need rigorous statistics to reach the market, but a full-time biostatistician often doesn't fit the org chart yet. Start with whichever section fits your question.

  1. § 1ServicesSAPs, CSRs, TFLs, interim analyses, post-market surveillance, SAS/R programming, EDC builds.
  2. § 2EngagementsProject-based, monthly retainer, or ad hoc. How a scoping call turns into a deliverable.
  3. § 3ExperienceFDA-CDRH review plus sponsor-side leadership at Abbott, Medtronic, Amgen, CryoCor, and Ionis.
  4. § 4AboutBackground, education, and selected peer-reviewed publications.
Contact

Ready to talk through your project?

Tell me a little about your study and what you need. I'll reply by email to set up a short scoping call.

LocationLoveland, Colorado · working with sponsors nationwide