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 practice helps critical projects in small to mid-size biotech, medtech, and pharma companies stand up to scrutiny.
I help clients solve important Real-World Evidence (RWE) challenges, succeed in high-stakes processes with FDA, EMA, Santé Canada, and other regulators 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 its 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.
The right expertise, at every stage.
Causal Inference
Move beyond association. Apply modern causal methods — propensity scores, quasi-experiments, DAGs — to build defensible cause-and-effect claims from complex data.
Real-World Evidence (RWE)
Transform observational and registry data into regulatory-grade evidence. Design robust RWE studies that complement or replace randomized trials where appropriate.
Statistical Advisory
Strategic statistical guidance for biotech and pharma teams navigating small to mid-size drug development programs — from protocol design through submission.
Training Workshops
Custom training programs for research teams and industry scientists. Hands-on sessions in biostatistics, causal inference, and R/Python — taught by a 10-year university lecturer.
Why Work With Me?
Experience
Experienced in high-stakes regulated biotech, pharma, and medtech research projects
Methodological Authority
Author of an advanced Causal Inference textbook and have trained hundreds how to perform credible, regulatory-grade work
Great Communicator
Lecturer at 2 world-class universities, ETS Montreal and HEC Montreal, Guest Lecturer and Invited Panelist
Statistics Thought-Leader
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…
Our collaborations have resulted in real business impact.
Dr. Victor Kang
Lead Scientist, Spotta
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
His technical expertise and statistical knowledge is exceptional.
Dr. Robert Whitley
Professor, McGill University
I would happily work with Justin again and definitely recommend him to others needing a statistical consultant.
Joshua Nasielski
Professor, Guelph University
Recurring Commitment
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Minimum Monthly Engagement Required
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Free Discovery Call
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I’ll Work Directly With Your Data
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I’ll Prepare Publication-Ready Figures
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Availabilities : Few Weeks to a Few Months
Project-Based
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Minimum Monthly Engagement Required
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Free Discovery Call
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I’ll Work Directly With Your Data
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I’ll Prepare Publication-Ready Figures
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Availabilities : Few Weeks to a Few Months
Express Consultation
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Minimum Monthly Engagement Required
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Free Discovery Call
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I’ll Work Directly With Your Data
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I’ll Prepare Publication-Ready Figures
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Availabilities : Now
My Guarantee: Regulatory-Grade Work That Withstands Scrutiny
When your submission is under FDA or EMA review, you need analyses that meet regulatory standards the first time. Every deliverable I produce:
- Follows ICH E9, 21 CFR Part 11, and applicable regulatory guidelines
- Includes complete documentation of methods, assumptions, and sensitivity analyses
- Can be confidently defended in advisory committee meetings or regulatory queries
If any statistical work fails to meet regulatory guidelines or scientific standards, I’ll revise it at no additional cost until it does.
Your regulatory success is my measure of success.