Ndoh Penn
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Curriculum Vitae

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Profile

Biostatistician with 5+ years in pharmaceutical clinical development, clinical assay statistics, and translational research. Experienced in longitudinal and repeated-measures models, time-to-event methods, Bayesian methods, and high-dimensional biomarker data. Strong R and SAS programmer with CDISC SDTM/ADaM expertise. Open-source enthusiast and developer of R (shiny) packages for regulated analytical workflows.


Experience

Open-Source Development · Reprostats · Belgium Oct 2025 – Present

  • Designed and built R packages including Bayesian prior elicitation, reproducibility for R projects, tamper-evident audit logging, and row-level data provenance (CDISC-compliant exclusion tracking).
  • Built IQ/OQ/PQ qualification suites for the regulog package, covering 21 CFR Part 11 §11.10, §11.100, §11.200 and EU Annex 11 Clauses 9 and 11.

Statistician – FSP · Enovalife · GSK · Brussels, Belgium May 2022 – Mar 2026

Vx Clinical Assay Statistics · Jul 2023 – Dec 2025

  • Led statistical design, analysis, and interpretation of clinical assay experiments supporting vaccine immunogenicity programmes.
  • Provided statistical expertise across assay development, validation, and lifecycle management including performance characterisation for pharmacodynamic and predictive endpoints.
  • Developed and executed statistical analysis plans.
  • Championed R adoption; designed and deployed R Shiny dashboards and analysis tools to enhance reproducibility, traceability, and reporting.

Vx Preclinical & Research Statistics · May 2022 – Jul 2023

  • Performed analysis of preclinical data supporting translational research questions.
  • Designed and implemented statistical analysis plans; conducted QC and compiled analysis reports.
  • Participated in cross-functional planning meetings on statistical methodology and experimental design.

Statistician – Health Data Scientist · INSERM · Bordeaux, France Jan 2020 – Mar 2021

  • Wrote and maintained statistical analysis plans for high-dimensional survival data studies incorporating biomarker endpoints.
  • Implemented advanced methods: time-to-event models, penalised regression, and machine learning-based prediction models.
  • Co-authored research communications.

Epidemiologist · Cameroon Society of Epidemiology (CaSE) · Yaoundé, Cameroon Sep 2015 – Aug 2016

  • Designed data collection tools; supervised vaccine programme epidemiological investigations and public health surveillance.

Open-Source R Packages

regulog CRAN

Tamper-evident, hash-chained audit logging. 21 CFR Part 11 & EU Annex 11. IQ/OQ/PQ validation suite.

lineager CRAN

Row-level data provenance and exclusion tracking. CDISC Reviewer's Guide-aligned reports.

reproducr CRAN

Reproducibility auditing — session capture, dependency locking, script certification, drift detection.

bayprior CRAN

Structured Bayesian prior elicitation, conflict diagnostics, and regulatory reporting.


Education

Degree Institution Year
M.Sc. Public Health Data Science University of Bordeaux, France 2019 – 2020
M.Sc. Applied Statistics & Biostatistics Hasselt University, Belgium 2016 – 2019
M.Sc. Epidemiology University of Buea, Cameroon 2013 – 2015
B.Sc. Microbiology University of Buea, Cameroon 2010 – 2013

Certifications

  • Advanced Certificate in Practical Applications of Bayesian Statistics in Clinical Trials · London School of Business & Research · Oct 2025 – Mar 2026
  • ICH Good Clinical Practice E6 (R2)
  • SAS Programming 2: Data Manipulation Techniques
  • SAS Macro Language · SAS Programming for R Users
  • SDTM001 – CDISC SDTM Implementation

Languages

English — Fluent · French — Advanced · Dutch — Basic


Technical Skills

Statistical methods: Mixed models, survival analysis, Bayesian methods, penalised regression, high-dimensional data analysis, biomarker statistics, time-series methods

Programming: R (advanced), R Shiny, SAS (advanced), Python (intermediate), Git, SQL

Standards & frameworks: CDISC SDTM/ADaM, 21 CFR Part 11, EU Annex 11, ICH E9(R1), GCP E6(R2)

R ecosystem: R Shiny & package development, testthat, pkgdown, devtools, Quarto, dplyr, ggplot2, haven, Rmarkdown

 

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