Quality Assurance in Statistical Programming

Statistical programming errors can derail clinical trials, compromise regulatory submissions, and undermine years of research investment.

As a specialized quality assurance consultant in statistical programming, I help you implement robust QA processes that ensure your analyses meet the highest standards of accuracy and regulatory compliance.

Whether you’re preparing SDTM/ADaM datasets, validating TFLs, or preparing for regulatory submissions, my expertise ensures your statistical programming deliverables are error-free and audit-ready.

Comprehensive Quality Assurance Services

Transform your statistical programming from error-prone to bulletproof with systematic QA processes.

My end-to-end quality assurance services help clinical research organizations and pharmaceutical companies deliver flawless statistical programming outputs.

Study Design & QA Planning

Establish robust quality control frameworks before programming begins.

  • Develop comprehensive QA plans aligned with regulatory requirements
  • Create statistical programming standards and SOPs specific to your organization
  • Design triple-check processes for critical programming deliverables
  • Establish quality metrics and acceptance criteria for all outputs
  • Plan validation strategies for complex statistical analyses
  • Create protocol adherence checklists and compliance matrices

SDTM/ADaM Compliance & Validation

Ensure your datasets meet regulatory standards and pass submission reviews. .

  • Comprehensive SDTM compliance validation using industry-standard checks
  • Complete ADaM dataset validation with metadata verification
  • Independent review of programming logic and derivation algorithms
  • Validation of analysis datasets against statistical analysis plans
  • Cross-reference verification between datasets and source documentation
  • Regulatory submission readiness assessment and gap analysis

TFL Quality Control & Verification

Deliver tables, listings, and figures that meet publication and regulatory standards.

  • Independent programming and verification of all TFL outputs
  • Statistical analysis plan adherence verification for every deliverable
  • Cross-validation of results using alternative programming approaches
  • Quality flags implementation for automated error detection
  • Comprehensive review of formatting, labeling, and presentation standards
  • Validation of statistical methods and computational accuracy

Programming Audit & Documentation Review

Thorough examination of your statistical programming practices and outputs.

  • Complete programming code review and optimization recommendations
  • Documentation assessment against regulatory and industry standards
  • Programming workflow evaluation and best practices implementation
  • Reproducibility testing across different computing environments
  • Version control and change management process validation
  • Quality control documentation and audit trail verification

Data Integrity & Error Detection

Systematic approaches to identify and prevent programming errors.

  • Advanced error detection using automated quality control checks
  • Data integrity validation across all programming outputs
  • Missing data handling and imputation method verification
  • Outlier detection and statistical assumption validation
  • Cross-study consistency checks for multi-protocol analyses
  • Real-time quality monitoring and alert systems implementation

Ongoing QA Support & Training

Beyond initial validation, I provide continuous quality assurance support.

  • Regular programming oversight and quality metric monitoring
  • Advanced training on statistical programming best practices
  • Methodology updates on evolving regulatory requirements
  • Support for regulatory agency responses and audit preparation
  • Quality improvement recommendations based on industry benchmarks
  • Strategic guidance on quality assurance process optimization
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Why Work With Me For Your Quality Assurance Needs?

Working with a QA specialist benefits you in multiple ways.

Time Efficiency

Focus on core research activities while I handle complex quality assurance requirements.

Reduced Stress

Navigate regulatory compliance challenges with confidence through systematic QA processes.

Accurate Results

Implement industry-leading quality control methods that prevent costly errors and ensure regulatory acceptance.

Use Results With Confidence

Your statistical programming outputs will meet the highest standards of accuracy, reproducibility, and regulatory compliance, giving you complete confidence in your submissions.

The Quality Assurance Process

My QA process is designed for thoroughness and regulatory compliance.

Discovery Phase

We connect to understand your quality assurance needs, current programming practices, regulatory requirements, and specific compliance challenges.

QA Framework Development

Together, we establish comprehensive quality control procedures, including validation strategies, acceptance criteria, and documentation standards. All deliverables and timelines are clearly defined in a formal Service Proposal.

Implementation & Validation

I execute systematic quality assurance activities, including independent programming verification, compliance validation, and comprehensive error detection across all deliverables.

Quality Documentation & Reporting

I deliver detailed QA reports with complete audit trails, validation summaries, quality metrics, and regulatory-ready documentation packages.

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 statistical programming quality assurance? From QA framework development to comprehensive validation services, I offer specialized expertise in regulatory compliance and programming excellence. Together, we can ensure your statistical programming meets the highest industry standards.

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Tools and Technologies

Advanced Statistical Software

Using R, SAS, and Python with validated programming environments, I ensure your quality assurance processes meet regulatory requirements and industry best practices.

Automated QA Systems

I implement sophisticated automated quality control systems that detect errors, validate compliance, and generate comprehensive quality reports for all programming deliverables.

Industry-Standard Validation

My experience spans all major statistical software platforms including SAS, R, Python, Stata, and specialized clinical programming tools, ensuring compatibility with your existing infrastructure.

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.