Project 21 · Biostatistics
PHARMA
ClinicalTrialEDA
Trial Analytics & Biomarker Discovery
01 Abstract
Trial Analytics & Biomarker Discovery
A notebook-driven exploratory analysis of a synthetic Phase III anti-inflammatory trial (RX-7281 vs placebo), demonstrating the biostatistics workflow behind a trial readout.
02 Highlights
Methods & contributions
- Inflammatory biomarker panel — CRP (mg/L), IL-6 (pg/mL), TNF-α (pg/mL), and ESR (mm/hr) with correct units throughout.
- Hypothesis testing — chi-squared, Mann–Whitney U, response-rate comparison, and a baseline-balance "Table 1".
- Biomarker discovery — scikit-learn predictors with SHAP attribution and survival curves via lifelines.
- Reproducible data — a seeded synthetic generator (1,200 patients) keeps the whole narrative deterministic.
03 Architecture
Data flow
synthetic generator → EDA → statistical testing
→ biomarker discovery (SHAP · survival)
04 Notebooks
Rendered Jupyter notebooks
The analysis narrative is captured in Jupyter notebooks, rendered to HTML for direct viewing.
05 Stack