Biotech & Biopharmaceutical Consulting Services

Statistical expertise that drives biotechnology innovation and regulatory success.

As a specialized biotechnology consultant, I provide comprehensive statistical support for biotech companies, research institutions, and biopharma organizations navigating complex data challenges.

From early-stage research through clinical trials and regulatory submissions, my expertise ensures your biotechnology projects meet the highest statistical standards while accelerating time-to-market.

Comprehensive Biotechnology Statistical Services

Transform your biotech data into compelling evidence for regulatory approval and commercial success.

My specialized statistical consulting services address the unique challenges faced by biotechnology companies, from research design to market authorization.

Clinical Trial Design & Analysis

Design and analyze clinical studies that meet regulatory requirements and maximize your chances of approval.

  • Phase I, II, and III clinical trial design with appropriate statistical power
  • Adaptive trial designs for efficient resource allocation
  • Biomarker identification and validation strategies
  • Interim analysis planning and data monitoring committee support
  • Regulatory submission preparation including statistical analysis plans
  • Post-marketing surveillance and real-world evidence studies

Biomanufacturing & Quality Control

Ensure product quality and manufacturing consistency through rigorous statistical methods.

  • Process validation and statistical process control implementation
  • Design of experiments (DOE) for bioprocess optimization
  • Statistical analysis of cell culture and fermentation data
  • Monoclonal antibody production quality assessment
  • Batch release testing and stability studies
  • Contamination risk assessment and control strategies

Genomics & Proteomics Analysis

Extract meaningful insights from complex omics datasets using advanced statistical methods.

  • Differential gene expression analysis and pathway enrichment
  • Genome-wide association studies (GWAS) design and analysis
  • Protein biomarker discovery and validation
  • Multi-omics data integration and systems biology approaches
  • Pharmacogenomics analysis for personalized medicine
  • Variant calling and annotation for genetic engineering applications

Preclinical Research Support

Strengthen your preclinical studies with robust statistical design and analysis.

  • In vitro assay development and validation
  • Animal model study design and power calculations
  • Dose-response modeling and pharmacokinetic analysis
  • Toxicology study design and safety assessment
  • Biocompatibility testing for medical devices
  • Target identification and validation studies

Regulatory Compliance & Submissions

Navigate complex regulatory requirements with confidence through expert statistical guidance.

  • FDA and EMA submission preparation and review
  • Statistical sections for IND, NDA, and BLA applications
  • Regulatory meeting preparation and statistical justification
  • Post-approval commitment study design
  • Pharmacovigilance and safety signal detection
  • Quality by design (QbD) implementation and documentation

Innovation & Technology Assessment

Evaluate emerging biotechnologies and assess their commercial potential through statistical analysis.

  • CRISPR gene editing efficiency and safety analysis
  • Synthetic biology pathway optimization
  • Agricultural biotechnology field trial design
  • Industrial biotechnology process economics
  • Patent landscape analysis and competitive intelligence
  • Technology transfer and licensing support
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Why Work With Me For Your Biotechnology Needs?

Working with a biotechnology statistics expert benefits you in multiple ways.

Regulatory Expertise

Navigate FDA, EMA, and other regulatory requirements with confidence and precision.

Industry Experience

Leverage deep understanding of biotech business models and technical challenges.

Scientific Rigor

Apply cutting-edge statistical methods that meet the highest scientific standards.

Commercial Focus

Ensure your statistical strategies align with business objectives and market requirements.

The Biotechnology Consulting Process

My biotechnology consulting process is designed for efficiency and regulatory compliance.

Discovery & Requirements

We begin with a comprehensive discussion of your biotechnology project, regulatory requirements, data availability, and specific statistical challenges you're facing.

Study Design & Protocol Development

Together, we develop a detailed statistical analysis plan that addresses your research objectives while meeting regulatory standards. This includes power calculations, endpoint selection, and risk mitigation strategies.

Data Analysis & Interpretation

I conduct rigorous statistical analyses using methods appropriate for biotechnology applications, handling complex issues like missing data, multiplicity, and regulatory-specific requirements.

Documentation & Reporting

I deliver comprehensive reports with regulatory-compliant documentation, publication-ready figures, and clear interpretations that support your business decisions and 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 help with your biotechnology statistical challenges? From clinical trial design to regulatory submissions, I offer specialized expertise that accelerates your path to market success.

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Tools and Technologies

Statistical Software Excellence

Using industry-standard tools like R, SAS, and Python, I ensure your biotechnology data meets the highest analytical standards while maintaining regulatory compliance.

Specialized Biotechnology Tools

I leverage specialized software for genomics analysis (Bioconductor, GATK), clinical trial management (SAS Clinical), and regulatory submissions, ensuring your analyses meet industry-specific requirements.

Data Integration Platforms

My expertise extends to complex data integration challenges common in biotechnology, including multi-omics data fusion, laboratory information management systems (LIMS), and clinical data management platforms.

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.