Standards-Driven Statistical Science Portfolio
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Alpha TRAORE
Senior Statistical Scientist
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  • 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

Standards-Driven Statistical Science Portfolio

A QC-first, traceability-driven portfolio demonstrating integrated work across:

  • Statistical Science (study strategy, estimands, confirmatory inference, modeling)
  • Programming & Data Standards (SDTM, ADaM, TLFs, validation, delivery readiness)

Built to reflect ICH-aligned, CDISC standards-driven practices, with emphasis on reproducibility, reviewer-friendly structure, and clear traceability from scientific planning to analysis outputs.

TipHow to navigate

Use the sidebar to browse the full structure, or start with the quick-access cards below. Each major area includes a landing page with section overview and navigation.

Explore the Portfolio

Part 1

Statistical Science

Scientific leadership, trial design and estimands, confirmatory inference,
statistical modeling, and QC/validation delivery readiness.
Leadership • Planning • Inference • Modeling

Part 2

Programming & Data Standards

Standards-driven implementation across SDTM, ADaM, and TLFs with validation,
traceability, and submission-supporting documentation.
SDTM • ADaM • TLF • Validation

Quick Pathways

Statistical Science (recommended starting points)

Scientific Leadership and Positioning

Study-level statistical leadership, decision support, and cross-functional collaboration.

Trial Design, Estimands, and Planning

Design strategy, estimands/intercurrent events, power planning, randomization, and SAP/TLF shell planning.

Confirmatory Inference and Robustness

Multiplicity, missing data considerations, and sensitivity analyses for credible interpretation.

Statistical Modeling

Applied modeling workflows and methods (MMRM, survival, PK/PD) with implementation context.

Quality, Validation, and Delivery Readiness

QC-first execution, validation discipline, traceability, and reviewer-ready packaging.

Programming & Data Standards (recommended starting points)

SDTM

Domain construction, standards alignment, validation/QC, and submission support artifacts.

ADaM

Analysis-ready datasets, derivation traceability, QC/validation, and ADRG-ready organization.

TLFs

Shell-aligned tables, figures, and listings with traceable ADaM linkage and review readiness.

What this portfolio emphasizes

QC-First Execution Traceability-First Design Standards-Driven Delivery Submission-Minded Organization Reviewer-Friendly Structure

Practical focus

This portfolio is designed to show a production-oriented approach to statistical and programming work in regulated clinical development settings—balancing:

  • Methodological rigor
  • Operational feasibility
  • Standards alignment
  • Review-ready quality

External Links

  • LinkedIn
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  • Credly
Statistical Science

© 2026 Alpha Traore

QC-First • Traceable • Standards-Driven

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