Survival Analysis: Cox Proportional Hazards
The Cox PH model, hazard ratios and handling censored data in oncology and survival endpoints.
Read tutorial →Clinical Biostatistics · Drug Development
Statistics for the people who actually develop medicines.
Clinical Biostats teaches the methods used in real clinical trials and regulatory submissions — and builds the interactive tools that put them to work.
Primary & Key Secondary Endpoints
HR / OR, 95% CIHow the site works
Go beyond textbook statistics.
Practical explanations built around clinical trials, regulatory submissions and real pharmaceutical development — not abstract theory.
01 · Learn
Clinical Methods
Regression, survival analysis, MMRM, Bayesian methods, multiplicity and missing data — explained the way they're actually applied in trials.
02 · Use
Interactive Tools
Sample size, power, dose-finding and adaptive design calculators you can run against your own trial parameters.
03 · Master
Applied Expertise
SAPs, TLFs, estimands, CDISC programming and the regulatory context that connects statistics to submissions.
Statistical Tools
Tools built for real trial design.
Every calculator on Clinical Biostats runs the same methods you'd defend in a protocol or SAP. This preview shows the Simon's Two-Stage Design calculator — open it to run it against your own trial assumptions.
Open Simon's Two-Stage CalculatorSimon's Two-Stage Design — Phase II Single-Arm
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Expected N Under H0 — EN(p0)
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Tutorials
Tutorials, from foundations to trial design.
Each tutorial works through the method's assumptions and a worked example. New topics are added regularly.
Dose-Finding: Bayesian Optimal Interval (BOIN)
Balancing dose escalation and patient safety using observed dose-limiting toxicity rates.
Read tutorial →Logistic Regression
A ground-up guide to modeling binary outcomes, from odds ratios to model interpretation.
Read tutorial →Clinical Trials
See the methods at work in real trials.
Statistical breakdowns of published Phase 2 and 3 trials: design, endpoints, estimates, confidence intervals and what the results actually mean, each linked to the tutorials behind its methods. New trials are added every week.
Cardiovascular · Phase 3
FOURIER
Evolocumab and cardiovascular outcomes: stratified log-rank testing, hazard ratios and multiplicity across a composite endpoint.
Read the analysis →Oncology · Phase 3
TAILORx
Adjuvant therapy guided by a genomic recurrence score: Cox proportional-hazards modeling and disease-free survival.
Read the analysis →Neurology · Phase 3
TRAILBLAZER-ALZ 2
Donanemab in early Alzheimer's disease: change-from-baseline endpoints analyzed with mixed models and ANCOVA.
Read the analysis →Tools
Interactive statistical tools.
Turn methodology into something you can actually run. Every calculator links out to its own dedicated page.
Design
Simon's Two-Stage
Optimal and minimax designs for single-arm Phase II oncology trials.
Dose-FindingTITE–BOIN
Time-to-event Bayesian optimal interval design for late-onset toxicities.
Design · Worked ExampleFleming's Two-Stage
Single-arm Phase II design as an alternative to Simon's methodology, worked step by step.
All CalculatorsSample Size & Power
Browse every calculator: superiority, non-inferiority and equivalence designs across common endpoint types.
Insights
Timely regulatory & methodological commentary.
Short, practical takes on guidance changes and methods debates that affect how trials get designed and analyzed — launching soon.
The first Insights piece is in progress.
This section will feature original commentary on regulatory guidance and methods debates as soon as the first pieces are published.
Built by an industry biostatistician
“The goal isn't to teach statistics in isolation. It's to teach statistics the way they're actually used to develop medicines.”PhD in Statistics · Pharmaceutical clinical development · BLA / MAA / IND experience
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Expert Discussions
Original commentary and practical takeaways from leading statisticians, researchers and quantitative scientists working in drug development.
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Explore tutorials, calculators and professional training built around real clinical trial statistics.