Selected Portfolio · 2026

Clinical data. Statistical rigor. Decisions you can defend.

I’m Alpha S. Traoré, a Principal Statistical Scientist with 9+ years supporting Phase I–III clinical development. I turn complex trial data into traceable, submission-ready analyses across oncology, rare disease, and PK/PD.

Principal-level leadership NDA · ISS · ISE delivery 5 professional credentials
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Greater Cincinnati, USA Principal Statistical Scientist
Portfolio overview
Alpha S. Traoré, Principal Statistical Scientist

Alpha S. Traoré

Principal Statistical Scientist

Clinical TrialsOncologyRare DiseasePK/PD
9+Years
Phase I–IIIDevelopment
20+Studies
NDA · ISS · ISESubmissions
SDTMStandardize
ADaMAnalyze
TLFsReport
SubmissionDeliver
SAS · R · CDISC · SDTM · ADaM
01 · Selected Work 02 · Expertise 03 · About 04 · Experience 05 · Credentials 06 · Contact
03

About me

Where statistical rigor meets practical delivery.

My work sits at the intersection of biostatistics, statistical programming, and clinical data strategy.

I transform complex trial data into dependable datasets, tables, listings, figures, and analytical tools. My experience spans Phase I–III clinical development, selected preclinical studies, oncology, rare disease, PK/PD, and integrated submission work, including NDA, ISS, and ISE deliverables.

I care about traceability, thoughtful validation, and process improvement. I develop reproducible analyses, analytical applications, and AI-enabled tools that strengthen data quality and support confident decisions—not just code that runs.

Primary focusClinical & life sciences
MethodsBiostatistics & programming
ApproachAccurate, clear, reproducible
02

Expertise

Focused capabilities across the clinical data lifecycle.

From raw clinical data to validated evidence and decision-ready reporting.

01

Statistical Programming

Analysis datasets, TLF development, validation, reusable macros, and regulatory-ready production workflows.

  • SAS and R
  • TLFs and validation
  • NDA, ISS and ISE
02

Clinical Data Standards

Traceable implementation of CDISC standards supporting consistent analysis and regulatory review.

  • SDTM and ADaM
  • Specifications
  • Define and traceability review
03

Biostatistics & Analytics

Clear analytical reasoning for clinical endpoints, patient characteristics, and complex research questions.

  • Oncology and rare disease
  • PK/PD analytics
  • Statistical interpretation
04

Analytics Applications

Reproducible applications and AI-enabled tools that improve data quality, streamline workflows, and make complex results easier to review and communicate.

  • R Shiny and Quarto
  • Dashboards and AI-enabled tools
  • Process improvement and automation
04

Experience

Bridging statistical science and programming to turn complex trial data into confident decisions.

Progressive responsibility from hands-on biostatistics to principal-level scientific leadership — 2017 to present.

2024—Present

Principal Statistical Scientist

BioSTAT Consultants Inc.

Promoted from Senior to Principal in 2026. Sets statistical strategy across 8 active programs, from study design through regulatory submission, and leads a cross-functional programming team—after two years owning end-to-end biostatistics and programming for 10 studies.

2026—PresentPrincipal Statistical Scientist
2024—2026Senior Statistical Scientist
2021—2024

Senior Statistical Programmer

Precision for Medicine

Built CDISC-compliant SDTM and ADaM pipelines and TLFs across 20+ studies in oncology and rare disease, including PK programming and integrated ADaM datasets for ISS/ISE in an NDA submission.

2017—2021

Biostatistician

BioSTAT Consultants Inc.

CTI Clinical Trial & Consulting Services

PPD

Built a foundation in biostatistics across three organizations—authoring SAPs, ADaM specifications, and ISS/ISE datasets for NDA submissions, and leading cross-functional teams of 4–8 on Phase I–III studies.

EducationMS in Statistics
EducationMaster’s in Economics & Business Management
LanguagesEnglish · French
01

Selected work

Technical work, clearly presented.

Four technical projects spanning oncology analytics, statistical science, CDISC implementation in R, and interactive clinical-data workflow design.

Featured case study · R

Oncology Treatment Analytics

An end-to-end R workflow that transforms synthetic patient demographics, diagnoses, and treatment records into analysis-ready clinical insights.

Diagnosis classification Time to treatment First-line regimen inference Baseline characteristics Data-quality review Publication-ready tables
47Synthetic patients
3Source datasets
4Analysis outputs
RtidyversegtsummarygtQuarto
View project page Source code
Technical portfolio · Quarto

Standards-Driven Statistical Science Portfolio

A comprehensive technical library connecting study strategy, estimands, modeling, SDTM, ADaM, TLFs, validation, and submission-readiness.

Trial design and estimands MMRM, survival and PK/PD SDTM and ADaM domains TLFs and validation
QuartoStatisticsSDTMADaMTLFs
View project page Source
CDISC presentation · R/Jupyter

CDISC Implementation Experiences Using R

Supporting notebooks from a CDISC Pediatric User Network presentation, demonstrating synthetic DM inputs, SDTM mapping, and ADSL creation.

Synthetic raw DM data SDTM-compliant DM mapping SDTM-based ADSL inputs ADSL generation
RJupyterCDISCSDTMADaM
View project page Source
Interactive platform · Front-end prototype

Clinical Data Workflow Platform

A functional portfolio prototype connecting aCRF annotation, SDTM and ADaM specifications, statistical programming, TLF development, traceability, validation findings, and submission readiness.

Nine workflow modules Three synthetic studies Validation and readiness views CSV and summary exports
HTMLCSSJavaScriptSDTMADaM
View project page Open demo
05

Certifications

Professional credentials across programming, pharmacometrics, and data standards.

Industry-recognized certifications from Certara, SAS, and CDISC.

View verified credentials
Certara Certified Phoenix WinNonlin PK/PD Modeler badge

Certara

Phoenix WinNonlin
PK/PD Modeler

Certara Certified Phoenix NLME Pharmacometrician badge

Certara

Phoenix NLME
Pharmacometrician

Certara Certified Phoenix WinNonlin NCA Analyst badge

Certara

Phoenix WinNonlin
NCA Analyst

SAS Certified Advanced Programmer for SAS 9 badge

SAS

Advanced Programmer
for SAS 9

CDISC Tabulate Certified badge

CDISC

Tabulate
Certified

Let’s connect

Have a clinical data challenge or an opportunity to discuss?

I’m always interested in thoughtful conversations about clinical statistics, programming, and data-driven research.

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