Statistical Consultant and Strategic Advisor

Real-World Evidence & Causal Inference for Regulatory-Grade Biostatistics in Pharma and Biotech

I’m Justin Belair – an international expert on data science and statistics, with a strong expertise in causal inference. My statistical consulting and freelance work help high-stakes projects in regulated industries stand up to scrutiny.

My collaborations help clients solve important Real-World Evidence (RWE) challenges, succeed in high-stakes regulatory processes for drug development, and solve R&D problems to optimize Return-On-Investment.My work often gets published in top peer-reviewed journals.

 

Based in Montreal, Canada, I offer a fully bilingual (French and English) statistical consultant service in USA, Canada, EU, UK, Asia, and all around the globe.

Your Challenges = My Solutions

Statistics are best done by experts, especially when the stakes are high.

Here are common challenges I’ve observed, and the solutions I provide.

With more than 10 years of experience teaching at the University level and building training and workshops in high-stakes regulated industries, I can design custom training programs and workshops to bring your team to the next level.

Choosing methods for complex confounding patterns in the data is a team effort: you, the subject-matter expert, and I, the statistician, can leverage modern causal inference tools (study design, Directed Acyclic Graphs (DAGs), quasi-experiments, propensity score methods, sensitivity analyses, etc.) to understand robust cause-and-effect relationships, yielding insights into the predictable effects of your decisions and actions

It feels good to have an expert in your corner. In a few hours, I can validate the statistical analyses that your team or your CRO provide, giving you confidence as a decision-maker.

Facing regulators can be intimidating, especially when so much is staked on their approval. My knowledge of regulatory guidelines and how to frame your work to maximize it’s regulatory credibility can help you clear this hurdle and unlock new markets for your products.

You have a project in mind and are wondering if there are Real-World Datasets (RWD)–internally or externally–that can answer your specific questions? I can help.

Receive guidance through the selection of appropriate outcomes/endpoints, statistical methods and sample sizes. Enhance the credibility of your project and increase its chances of regulator buy-in.

Together, we can design experiments that bring concrete results, helping you balance scientific rigor and cost.

There is a rapidly emerging trend to incorporate causality based-principles in machine learning and AI models. Using a predictive models relies solely on correlations, but my expertise can show you how to teach the model about the cause-and-effect relationships in the data that to overcome the “correlation is not equal to causation” conundrum.

Sometimes, it just feels good to go over questions with a professional. Fill out a contact form saying you need Immediate Help and your request will be promptly addressed.

Why Work With Me?

Experience

Experienced in high-stakes regulated biotech, pharma, and medtech research projects

Great Communicator

Lecturer at 2 world-class universities, ETS Montreal and HEC Montreal

Methodological Authority

Author of an advanced Causal Inference textbook and have taught hundreds how to perform credible, regulatory-grade work

Statistics Thought-Leader

I’m followed by 25k professionals on LinkedIn, share industry insights through The Biostatistics Group blog, and over 1k+ students and professionals get insights from my newsletter and my online courses

Save Yourself Scientific Investigation Stress

Use The Right Data

Find and validate Real-World Datasets (RWD), perform data fitness audits, boost analysis quality, and get regulatory-grade results

Study Design and Statistical Analysis Plan (SAP)

Create a rigorous research plan that follows ICH E9 and that regulators will be happy to accept

Statistical Methods

I use methods from the appropriate FDA, EMA, and ICH guidelines to draw trusted inferences from your data

Regulator-Ready Results

Figures, texts, actionable insights, all documented with the utmost rigour, conforming to FDA 21 CFR Part 11

Trust and Communication

High-stakes leaders want clarity—my communication style builds this trust and transparency from the get-go, a valuable asset for regulatory submissions

Ethics and Conduct (GxP)

I go above and beyond the GxP frameworks and adhere to the utmost ethical scientific conduct—transparency can go a long way for regulatory buy-in

Don’t Just Take My Word For It…

Real-life examples of how research projects have succeeded that attest to the trustworthiness I consistently strive towards and the impact of my collaborations.
5/5

Our collaborations have resulted in real business impact.

Dr. Victor Kang

Lead Scientist, Spotta

5/5

He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English.

Elsa Brunet-Ratnasingham

Scientist, Arda Therapeutics

5/5

His technical expertise and statistical knowledge is exceptional.

Dr. Robert Whitley

Professor, McGill University

5/5

I would happily work with Justin again and definitely recommend him to others needing a statistical consultant.

Joshua Nasielski

Professor, Guelph University

Recurring Commitment

$
  • Minimum Monthly Engagement Required
  • Free Discovery Call
  • I’ll Work Directly With Your Data
  • I’ll Prepare Publication-Ready Figures
  • Availabilities : Few Weeks to a Few Months

Project-Based

$$
  • Minimum Monthly Engagement Required
  • Free Discovery Call
  • I’ll Work Directly With Your Data
  • I’ll Prepare Publication-Ready Figures
  • Availabilities : Few Weeks to a Few Months
Popular

Express Consultation

$$$
  • Minimum Monthly Engagement Required
  • Free Discovery Call
  • I’ll Work Directly With Your Data
  • I’ll Prepare Publication-Ready Figures
  • Availabilities : Now
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My Guarantee:
Your Satisfaction is My Priority

A satisfying collaboration is my ultimate goal. Any issues you may encounter will be promptly addressed. My commitment extends beyond delivering satisfactory analyses; I strive to exceed expectations. 

Are you ready to work hand-in-hand with an expert towards your research goals?