Biostatistics and Clinical Trial Design: Advanced

Biostatistics and Clinical Trial Design: Advanced

Survival Analysis, Estimands & the SAP

Biostatistics and Clinical Trial Design: Advanced

Develop survival analysis, randomization and blinding with ITT, multiplicity and missing-data handling, adaptive designs and the ICH E9(R1) estimand framework, and build a Statistical Analysis Plan outline.

RAQ-650-AAdvanced32 hoursCertificate of Completion

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Biostatistics and Clinical Trial Design
FormatProfessional Certificate Course
LevelAdvanced
Duration32 hours
LanguageEnglish
CertificateCertificate of Completion: Aleph University
Full course trackIntroductory (16 h) + Advanced (32 h) = 48 hours
Prerequisite / Recommended Preparation

Recommended prerequisite: completion of the Introductory level for this training, or relevant professional experience subject to Aleph University review.

Overview

Building on the inference and regression foundation of the Introductory level, this Advanced course develops the survival, integrity and estimand disciplines that a Statistical Analysis Plan requires.

This 32-hour Professional Certificate Course covers survival analysis (Kaplan-Meier, Cox proportional hazards), randomization and blinding with intention-to-treat analysis, multiplicity adjustment (Bonferroni, Hochberg) and missing-data handling (multiple imputation), and adaptive designs and the ICH E9(R1) estimand framework.

By the end, participants can draft a SAP outline, justify a sample-size calculation, produce a survival analysis on a trial dataset and choose an estimand strategy aligned with the clinical and regulatory question.

What you will learn
Build a Kaplan-Meier and Cox-regression analysis.
Evaluate estimand strategies under ICH E9(R1).
Handle multiplicity and missing data appropriately.
Develop a Statistical Analysis Plan outline.
Communicate biostatistical reasoning to regulators and clinical investigators.
course topics & modules
Professional relevance

The Advanced course connects survival analysis, multiplicity, missing data and estimands to the Statistical Analysis Plan, preparing participants to develop and review SAPs and clinical-study reports.

Certificate of Completion

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.

Completion of both the Introductory and Advanced levels may be reviewed by Aleph University for potential recognition within an applicable graduate pathway, subject to institutional review and applicable academic policies. Recognition is not automatic and is not guaranteed.
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