About us
Statistical rigor at every stage of clinical research
Stat-Aid Consulting was founded to bridge the gap between academic statistical methodology and the practical demands of regulatory clinical research. We work with sponsors, CROs, and academic medical centers to ensure every analysis is defensible, reproducible, and submission-ready.
Our mission
Our mission is to make rigorous statistical methodology accessible to every clinical research team — regardless of size or therapeutic area.
Scientific integrity
We never compromise on methodology. Every analytical decision is documented, justified, and peer-reviewed internally before delivery.
Regulatory fluency
Our team stays current with FDA, EMA, and ICH guidance. We anticipate reviewer questions and address them proactively in every submission package.
Reproducibility
All analyses are conducted in version-controlled, documented environments. Any result we deliver can be independently reproduced from raw data.
Transparent communication
We explain statistical concepts clearly to non-statistician stakeholders and flag methodological concerns early — before they become regulatory issues.
Our team
Experienced clinical biostatisticians
Principal Biostatistician
Dr. Margaret Holloway
PhD Biostatistics, Johns Hopkins Bloomberg School of Public Health
15+ years of experience in Phase II–IV clinical trials across oncology and cardiovascular indications. Former FDA statistical reviewer. Expert in adaptive trial designs and Bayesian methods.
Oncology · Cardiovascular · Adaptive designs
Senior Statistical Consultant
Dr. James Okafor
PhD Statistics, University of Michigan
Specializes in longitudinal data analysis, mixed-effects models, and real-world evidence studies. Extensive experience supporting NDA and BLA submissions for mid-size pharma sponsors.
Rare disease · Real-world evidence · Regulatory submissions
Statistical Programmer & Analyst
Dr. Priya Nair
MS Biostatistics, University of Minnesota
Expert in CDISC standards (SDTM, ADaM), TLF production, and SAS/R programming for clinical data. Leads all statistical programming and data validation workflows.
CDISC · SAS/R · TLF production
Our process
How we work
01
Discovery call
We begin with a structured intake to understand your study design, data structure, regulatory pathway, and timeline.
02
Statistical analysis plan
We author or review your SAP, ensuring all primary and secondary endpoints are pre-specified with appropriate statistical tests and multiplicity adjustments.
03
Analysis & programming
All analyses are conducted in documented, reproducible code (SAS or R). Outputs are validated by a second independent statistician.
04
Reporting & delivery
We produce publication-ready tables, listings, and figures, and draft or review the statistical sections of your clinical study report.
Ready to work together?
Tell us about your study and we'll respond within one business day.