Regulatory Biostatistics & Clinical Trials Workshops
Design and execute trials that meet global regulatory standards and speed time to market.
Hands-on workshop that gives your statisticians, clinicians, and regulatory teams the exact tools, templates, and decision frameworks used in successful FDA, EMA, and PMDA submissions.
Workshop Specialities
Clinical Trial Design & Sample Size
Design efficient trials with precise power and optimal resource allocation
- Choose optimal Phase I–IV designs for your molecule and indication
- Perform precise sample size and power calculations (including adaptive or sequential designs)
- Write defensible design sections for protocols and briefing books
- Simulate operating characteristics before finalising the design
- Templates accepted in recent approvals
Adaptive Designs & Interim Analysis
Maximize flexibility while maintaining statistical integrity
- Group-sequential, sample-size re-estimation, and population enrichment designs
- Alpha spending functions and binding futility boundaries
- Blinded and unblinded sample-size re-estimation in practice
- Write adaptive SAPs that pass FDA/EMA scrutiny
- Real code and simulation workflows in R and SAS
CDISC Standards & Submission-Ready Deliverables
Deliver flawless regulatory datasets and documentation
- Produce perfect SDTM and ADaM datasets from raw CRF data
- Create Define.xml, Reviewer's Guide, and analysis results metadata
- Build and validate all standard TLFs (Tables, Listings, Figures)
- End-to-end Pinnacle 21 validation and error resolution
- Leave with a complete submission package template
Multiplicity & Estimand Framework (ICH E9 R1)
Align your trials with modern regulatory expectations
- Implement the five-part ICH E9(R1) estimand framework in your protocols
- Choose and justify appropriate multiplicity strategies (graphical, gatekeeping, fixed-sequence)
- Handle intercurrent events (ITT, while-on-treatment, per-protocol)
- Write estimand sections that prevent Type C meeting questions
- Real examples from approved NDAs/BLAs
Crafting Compelling Narratives in Real-World Evidence
Tell persuasive stories that regulators trust and approve
- Implement the five-part ICH E9(R1) estimand framework in your protocols
- Promote transparency and open communication standards for regulators
- Label expansion capabilities
- Mock regulator meetings and protocol development to help your team practice
- Case studies from drug development, pharmacovigilance, and more
Handling Missing Data & Sensitivity Analyses
Protect your primary results with robust sensitivity strategies
- MAR, MNAR, and tipping-point sensitivity analyses regulators expect
- Multiple imputation, pattern-mixture models, and delta-adjustment
- Write missing-data plans that satisfy FDA and EMA
- Primary analysis + full suite of sensitivity/supportive analyses
- Ready-to-use code and reporting templates
Regulatory Interaction & Statistical Review Defence
Navigate FDA/EMA review with confidence and strategic preparation
- Anticipate and prepare for FDA/EMA statistical review questions
- Draft responses to complete response letters and Day-120 questions
- Present statistical results at advisory committee meetings
- Case studies from recent successful interactions
- Return ready to lead your next regulatory submission
Bring practical, regulator-focused training directly to your team. Through hands-on workshops I deliver modern biostatistics, causal inference, and industry-standard tools, transforming complex data into clear, submission-ready insights that accelerate approvals and strengthen your pipeline.
Flexible Delivery Options
Intensive Multi-Day Workshops
Typically 2–5 day intensive programs. Fully flexible to match your timeline. Featuring hands-on projects and real-world case studies. Certificate of completion included.
Custom In-House Training
Fully tailored programs at your facility or virtual. Aligned with your tools, processes, and therapeutic areas.
Modular Course Series
Monthly or quarterly workshops for continuous skill development from beginner to advanced levels.
On-Demand Support
Post-training consultation for specific project challenges and expert review of analyses.
Organizations We Train
Pharmaceutical & Biotech
Drug developers, medical affairs, regulatory departments, CROs
Academic Research
Universities, hospitals, government research labs
Public Health
Government agencies, parapublic institutions
Medical Device & MedTech
R&D, clinical affairs, post-market surveillance
Real Applications
12-Hour RWE Intensive for Pharma Company
Delivered a library of training material that is re-used to train and onboard new analysts.
Quarterly Causal Inference Series for Biotech
Monthly office-hours to tackle any challenges faced by client’s teams through Q&A and open discussions about potential solutions and foreseeable difficulties.
Regulatory Biostatistics Onboarding for CRO
Custom small group training to review and enhance statistical analyses of complex biotechnology experiments. Developed re-usable templates tailored to client’s needs for future statistical analyses.
Expert Consultant & Educator
University Teaching Experience
Lecturer at HEC Montreal and ETS Montreal with proven methods for making complex concepts accessible.
Real-World Consulting
Daily work with pharma and biotech organizations ensures training reflects current industry practices.
Thought Leader
Audiences of thousands follow me online for deep and incisive thought-leadership in biostatistics
Customized Content
Tailored to your therapeutic areas, software, regulatory needs, and team levels.
Ongoing Support
Follow-up assistance to ensure successful application of new skills.
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