NoyMed Academy Certified Biostatistician
Design and analyze clinical trials to regulatory standard - from estimands to the statistical analysis plan.
About this program
A comprehensive program for statisticians moving into, or upskilling within, clinical trials. It covers trial design, the estimand framework, sample size, the statistical analysis plan, and the reporting expectations of a regulatory submission.
Who it is for
Statisticians, data scientists, and quantitative researchers entering clinical trials, or early-career trial statisticians formalizing their skills.
Prerequisites
- Working knowledge of applied statistics (regression, hypothesis testing)
- Comfort with R or SAS
- Bachelor's degree in statistics, mathematics, or a related quantitative field (or equivalent experience)
Curriculum outline
1. Foundations of clinical trial design
Trial phases, randomization, blinding, control types, and endpoints.
Topics: Phases I–IV · Randomization schemes · Endpoint selection · Bias and its control
2. The estimand framework
ICH E9(R1): defining what a trial is actually estimating.
Topics: Treatment effect definitions · Intercurrent events · Estimand strategies · Sensitivity analyses
3. Sample size and power
Powering a study for its primary estimand.
Topics: Effect size assumptions · Power curves · Adaptive re-estimation · Multiplicity
4. The statistical analysis plan
Authoring a regulator-ready SAP.
Topics: Analysis populations · Handling missing data · Pre-specification · Mock shells
5. Analysis and reporting
From locked database to CSR statistical inputs.
Topics: TLFs · Interim analyses and DSMBs · Reproducible reporting · Submission datasets (ADaM overview)
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