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  1. Statistical Science
  2. MMRM

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Alpha TRAORE
Senior Statistical Scientist
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  • Statistical Science
    • Scientific Leadership and Positioning
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    • Study Design Overview
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    • Multiplicity
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    • Statistical Modeling
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    • Modeling Overview
    • MMRM
    • Survival Analysis
    • PK/PD
    • Quality, Validation, and Delivery Readiness
    • QC and Validation
  • Programming & Data Standards
    • SDTM
    • SDTM Overview
    • Domains (with Specs)
    • SDTM DM (Demographics)
    • SDTM AE (Adverse Events)
    • SDTM VS (Vital Signs)
    • Submission Package
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    • Outputs
    • Define XML
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    • Validation Summary
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    • ADaM
    • ADaM Overview
    • Domains (with Specs)
    • ADaM ADSL (Subject-Level Analysis Dataset)
    • ADaM ADAE (Adverse Events Analysis Dataset)
    • ADaM ADVS (Vital Signs Analysis Dataset)
    • ADaM ADTTE (Time-to-Event Analysis Dataset)
    • Submission Package
    • Outputs
    • Define
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    • Programs
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    • QC
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    • TLFs
    • TLF Overview
    • Tables
    • Table 1: Demographics
    • Table 2: TEAE by SOC/PT
    • Table 3: Table 3: PFS Summary
    • Table 4: Table 4: ORR
    • Table 5: Heart Rate Change
    • Figures
    • Figure 1: Cumulative Incidence Function (CIF) Plot (PFS)
    • Figure 2: PFS Kaplan–Meier
    • Figure 3: BMI Over Time by Treatment
    • Listings
    • Listing 1: Demographics & Baseline (Analysis Set)
    • Listing 2: TEAEs by SOC/PT
    • Listing 3: ORR

Table of contents

  • Deliverables
  • Programs and Outputs (HTML)
  • What you’ll find here
  • Model components (typical)
  • QC checklist
  1. Statistical Science
  2. MMRM

MMRM

Longitudinal endpoints • covariance structure • estimand-aligned inference

TipGoal

Analyze change-from-baseline longitudinal endpoints using MMRM, aligned with clinical trial conventions and estimand-focused reporting.

Deliverables

Specifications / Notes

  • MMRM Analysis Spec / Model Notes

Programming

  • MMRM Analysis Program

Programs and Outputs (HTML)

  • MMRM Output Report

What you’ll find here

  • Purpose: Repeated-measures inference for continuous endpoints across visits
  • Traceability: Analysis dataset → visit mapping → model specification → results
  • Typical outputs: LS-means by visit, treatment differences, CI/p-values, fit diagnostics

Model components (typical)

  • Fixed effects: TRT, VISIT, TRT×VISIT
  • Baseline covariate (and optionally baseline×visit)
  • Subject as repeated unit
  • Covariance: UN / AR(1) / CS (per SAP or justified via diagnostics)

QC checklist

  • Baseline definition: Consistent baseline window and parameter alignment
  • Visit mapping: Windowing rules clearly documented
  • Convergence: Diagnostics captured; sensitivity to covariance choice
  • Sensitivity: Alternative covariance structures / model variants (when needed)
Modeling Overview
Survival Analysis

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