Regulatory Biostatistics Solutions

Navigating FDA and EMA statistical requirements requires specialized expertise and meticulous attention to detail.

As a regulatory biostatistics consultant, I help pharmaceutical companies and research organizations meet stringent regulatory standards while maximizing the likelihood of successful submissions.

Whether you’re preparing an IND, NDA, or BLA submission, my expertise ensures your statistical analyses meet regulatory expectations and support your approval pathway.

Comprehensive Regulatory Biostatistics Services

Transform your clinical data into submission-ready statistical evidence.

My end-to-end regulatory biostatistics services help you navigate complex regulatory requirements from protocol design through final submission.

Statistical Analysis Plans & Protocol Development

Create robust SAPs that meet regulatory standards and support approval decisions.

  • Develop comprehensive statistical analysis plans aligned with ICH E9 guidelines
  • Design primary and secondary endpoint analyses for regulatory endpoints
  • Plan interim analyses and data monitoring committee procedures
  • Structure statistical sections for regulatory protocols
  • Define statistical methods for handling missing data and multiplicity
  • Create analysis populations and sensitivity analysis frameworks

IND & Early Phase Statistical Support

Build strong statistical foundations for investigational new drug applications.

  • Design dose-escalation studies with appropriate statistical stopping rules
  • Develop statistical methods for first-in-human studies
  • Create safety monitoring plans and statistical safety analyses
  • Prepare IND statistical sections meeting FDA requirements
  • Design proof-of-concept studies with regulatory-appropriate endpoints
  • Establish statistical frameworks for biomarker validation

NDA & BLA Statistical Analysis

Deliver comprehensive statistical analyses for new drug and biologics applications.

  • Conduct efficacy analyses meeting FDA and EMA statistical guidelines
  • Perform integrated safety analyses across clinical development programs
  • Execute population pharmacokinetic and pharmacodynamic analyses
  • Develop statistical sections for regulatory dossiers
  • Create comprehensive statistical reports for regulatory submissions
  • Conduct benefit-risk statistical assessments

Regulatory Submission Strategy & Documentation

Ensure your statistical approach aligns with regulatory expectations.

  • Develop regulatory submission strategies based on statistical evidence
  • Create statistical review documents for regulatory agencies
  • Prepare responses to regulatory statistical questions
  • Design post-marketing statistical surveillance plans
  • Develop statistical sections for regulatory guidance meetings
  • Create statistical documentation for regulatory compliance

Statistical Programming & Validation

Implement validated statistical programming for regulatory submissions.

  • Develop SAS programs following regulatory data standards
  • Create CDISC-compliant datasets for regulatory submissions
  • Implement statistical validation procedures for regulatory compliance
  • Generate regulatory-standard statistical outputs and tables
  • Develop reproducible statistical programming workflows
  • Ensure statistical data integrity throughout the submission process

Ongoing Regulatory Support

Beyond initial submissions, I provide:

  • Expert guidance on regulatory statistical requirements
  • Support for regulatory agency meetings and interactions
  • Assistance with post-approval statistical commitments
  • Training on regulatory biostatistics best practices
  • Review of statistical sections in regulatory documents
  • Updates on evolving regulatory statistical guidelines
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Why Work With Me For Your Regulatory Biostatistics Needs?

Working with a regulatory biostatistics expert benefits you in many ways.

Time Efficiency

Focus on drug development while I handle complex regulatory statistical requirements.

Reduced Risk

Minimize regulatory delays through compliant statistical approaches from the start.

Regulatory Expertise

Leverage deep knowledge of FDA, EMA, and ICH statistical requirements for successful submissions.

Submission Confidence

Present statistical evidence that directly supports regulatory approval decisions with robust, compliant analyses.

The Regulatory Biostatistics Process

My consulting process is designed for regulatory success and compliance.

Regulatory Assessment

We connect to understand your regulatory pathway, statistical challenges, data landscape, and specific FDA or EMA requirements for your indication.

Statistical Strategy Development

Together, we establish the regulatory statistical approach, including analysis plans, endpoint strategies, and submission timelines. All deliverables are outlined in a formal Service Proposal.

Analysis Implementation & Validation

I execute your statistical analyses using validated programming, ensuring compliance with regulatory data standards and statistical guidelines throughout the process.

Regulatory Deliverables

I deliver comprehensive statistical reports, regulatory-ready outputs, validated programming code, and statistical sections formatted for regulatory submissions.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

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-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need regulatory biostatistics support? From statistical analysis plans to complete submission packages, I provide expertise that meets regulatory standards. Together, we can navigate the complexities of regulatory submissions successfully.

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Tools and Technologies

Using industry-standard statistical software including SAS, R, and Python, along with regulatory-compliant programming practices, I ensure your analyses meet the highest regulatory standards.

I implement validated statistical programming workflows that comply with regulatory data standards, including CDISC SDTM and ADaM structures, ensuring seamless integration with regulatory submission processes.

I've worked extensively with regulatory submission systems and have experience with FDA and EMA statistical requirements across therapeutic areas.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.