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  1. Statistical Science
  2. Survival Analysis

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Alpha TRAORE
Senior Statistical Scientist
  • Home
  • Statistical Science
    • Scientific Leadership and Positioning
    • Statistical Study Leadership
    • Trial Design, Estimands, and Planning
    • Study Design Overview
    • Estimands and Intercurrent Events
    • Sample Size and Power
    • Randomization and Blinding
    • SAP and TLF Shells
    • Confirmatory Inference and Robustness
    • Multiplicity
    • Missing Data
    • Sensitivity Analyses
    • Statistical Modeling
    • Modeling Methods
    • 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
    • Case Report Forms
    • Outputs
    • Define XML
    • SDRG
    • Build & Quality
    • Programs
    • Validation Summary
    • QC
    • Standards
    • 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
    • ADRG
    • Build Quality
    • Programs
    • Validation
    • QC
    • Standards
    • 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
  • Core deliverables (typical)
  • QC checklist
  1. Statistical Science
  2. Survival Analysis

Survival Analysis

KM • Cox • diagnostics • explicit censoring and estimand clarity

TipGoal

Deliver time-to-event analyses that are estimand-aligned, with explicit event/censoring rules and reproducible outputs.

Deliverables

Specifications / Notes

  • Survival Analysis Spec / Notes

Programming

  • Survival Analysis Program

Programs and Outputs (HTML)

  • Survival Output Report

What you’ll find here

  • Purpose: KM/Cox workflows consistent with clinical reporting expectations
  • Traceability: ADTTE-like dataset → event/censoring definitions → model → outputs
  • Typical outputs: KM plot + at-risk, medians, HR/CI, PH diagnostics, sensitivity checks

Core deliverables (typical)

  • Kaplan–Meier plot (with at-risk table)
  • Event counts and median survival (with CI)
  • Cox model hazard ratio (HR) with CI (stratified when required)
  • Diagnostics: proportional hazards checks (when applicable)

QC checklist

  • Event definition: Precisely stated; consistent across outputs
  • Censoring rules: Explicit and testable
  • Time origin: Clear (randomization, first dose, etc.)
  • Sensitivity: Alternative censoring or model variants (as needed)
MMRM
PK/PD

© 2026 Alpha Traore

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