Stef De Reys, PhD

Practical Statistics Course for Medical Affairs: Interpretation & Application

With Stef De Reys, PhD

Course Details

THE CONTENT

Medical Affairs professionals are expected to interpret clinical data confidently, yet statistics often remain a source of uncertainty. Many Medical Affairs professionals can read clinical results but feel less confident interpreting the statistics behind them, especially what the numbers actually say about reliability, uncertainty, and clinical relevance.

This highly practical course provides a non-mathematical, Medical Affairs–focused approach to understanding and applying statistics. Using real clinical examples, you will learn how to interpret p-values, confidence intervals, hazard ratios, survival curves, AE/SAE tables, and forest plots in a meaningful and clinically relevant way. 

You will also learn how to spot common pitfalls, recognise misleading claims or visuals, and assess whether a result is statistically significant and clinically important.

Finally, you will gain practical tools to communicate data responsibly.

If you want to strengthen your ability to evaluate evidence and translate statistics into credible Medical Affairs insights, this course is a must-attend!
 


THE EXPERT

Stef De Reys, PhD, is a medical statistics expert with over 30 years of experience applying biostatistics across research, Medical Affairs, and commercial functions. 

  • As an independent consultant, Stef helps biotech and life science companies use data to optimise processes and make evidence-based strategic decisions. 

  • He has held global Medical Affairs positions for international companies, where he used data and analytics to improve Medical Affairs operations, from evidence-generation planning to field medical strategy and performance measurement.

  • Stef is known for his ability to translate complex statistical outcomes into simple, clinically meaningful messages, making data feel less abstract and more directly applicable to daily practice and long-term strategy.
     


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for Medical Affairs professionals, including MSLs, Medical Managers, Medical Information specialists and others who work with clinical evidence and want greater confidence in interpreting and communicating statistics.

Through expert-led teaching, real-life cases, and interactive group exercises, you will learn how to interpret clinical trial results, survival curves, and meta-analyses, and how to communicate findings in a fair-balanced, compliant, and audience-appropriate way. The sessions include practical examples, hands-on interpretation tasks, and peer discussions to help you build skills you can apply immediately in your daily Medical Affairs role. 

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

 

  1. How to recognise and avoid common pitfalls in statistical thinking that lead to incorrect interpretation of data.

  2. How to interpret key statistical outputs in clinical trials, including p-values, confidence intervals, hypothesis testing, Type I/II errors, and safety data (AE/SAE tables) from different study designs.

  3. How to interpret survival analyses, including Kaplan–Meier curves, hazard ratios, proportional hazards, and crossing curves.

  4. How to interpret meta-analyses, including forest plots, heterogeneity, and the statistical limits of meta-analysis.

  5. How to communicate statistical findings clearly, fairly, and compliantly, including recognising spin, avoiding misleading visuals, tailoring messages and applying good-practice templates.

Course agenda

 

 

Welcome & General Introduction  (~15 min)
The Importance of Proper Statistical Thinking and Interpretation in Medical Affairs  (~30 min)
  • Why correct statistical interpretation is essential in Medical Affairs: ensuring scientific credibility, fair-balanced communication, and informed decision-making
  • Common real-world challenges and pitfalls that make statistical results difficult to interpret correctly in daily Medical Affairs practice
  • Real-world examples of common violations of assumptions and of correct interpretation of statistical results
Reading Clinical Trial Results: From Statistically Significant to Clinically Relevant  (~1 h 15 min)
  • How to recognise study designs and start a structured statistical interpretation 
  • Overview of different data types and measurement scales
  • Statistical significance vs clinical relevance when assessing real-world impact:
    • Why confidence intervals often matter more than p-values for the interpretation of certainty and effect size
    • How hypothesis testing is used to decide whether an observed difference in a trial is likely real or due to chance 
    • Type I and Type II errors: The basics of false positives and false negatives in trials, and how these uncertainties influence interpretation
  • Basics of interpreting safety and tolerability data:
    • Understanding key risk indicators in clinical trials and what they mean for patient benefit
    • How to read Adverse Event and Serious Adverse Event tables like a pro
    • Group exercise: In groups, attendees will interpret a safety-summary slide. Findings will be discussed in plenary
  • “Do try this at home”: examples of common interpretation problems and practical solutions
Survival Curves Demystified: What They Mean for Patient Outcomes (~1 h 30 min)
  • How to read Kaplan–Meier plots correctly: understanding events, median OS/PFS, time to first AE, censoring
  • Clear explanation of what hazard ratios represent, when the proportional-hazards assumption matters, and how crossing curves affect the interpretation of treatment benefit
  • Three practical cases from different therapeutic fields: 
    • How to interpret Kaplan–Meier curves and forest plots
    • What you can and cannot legitimately conclude 
Lunch Break
Making Sense of Meta-Analysis (~1 h 30 min)
  • Learn what you can and cannot infer from pooled data
  • Understand heterogeneity conceptually (no formulas) 
  • Checklist: five questions before using meta-analysis in a slide deck
  • Group exercise: Attendees work in groups to review a forest plot and assess what the pooled evidence does and does not support, followed by a plenary debrief 
Fair-Balanced Communication & Critical Interpretation of Clinical Data (~1 h 15 min)
  • How to translate trial data into fair and balanced statements that communicate meaningful insights to stakeholders
  • Data visualisation best practices: 
    • Do’s & don’ts in creating clear, non-misleading graphs, tables and charts
    • How to recognise cherry-picking and visual manipulation
  • Spotting spin and misleading statistics: training the eye to spot overstatements or misinterpretations in competitor data or press releases
  • Clear, practice-oriented examples of how to keep statements compliant, non-promotional, and aligned with the label in everyday Medical Affairs communication
  • How to tailor your message to your audience:
    • Communicating statistical findings to a lay patient audience
    • Communicating statistical findings to a data-KOL
  • Practical templates and ready-to-use checklists to help create clear, accurate, and non-misleading charts for Medical Affairs communication 
Quiz, Wrap-Up & Q&A (~45 min)
  • 10-question interpretation quiz (no formulas)
  • “What I take away” summary per module
  • Open Q&A

 

Download Brochure

 

Complete the form below to download the course brochure and discover the full agenda, what you will learn, who you will learn from, and what past participants have to say.

 

UPCOMING DATES & FORMATS - FEES

11 March 2026

Live online

Early bird € 1 570

(until 06/02/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

People attending this course are typically also interested in the below courses. 

Need help to find the right course? Email Inge Cornelis or call +32 473 65 15 77.

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Course Details

Dates & Locations

11 March 2026

Live online

Register

Upcoming Session

11 March 2026, Live online

Early bird € 1 570

(until 06/02/2026)

 (Full fee € 1 770)

Prices are excl. VAT

THE CONTENT

Medical Affairs professionals are expected to interpret clinical data confidently, yet statistics often remain a source of uncertainty. Many Medical Affairs professionals can read clinical results but feel less confident interpreting the statistics behind them, especially what the numbers actually say about reliability, uncertainty, and clinical relevance.

This highly practical course provides a non-mathematical, Medical Affairs–focused approach to understanding and applying statistics. Using real clinical examples, you will learn how to interpret p-values, confidence intervals, hazard ratios, survival curves, AE/SAE tables, and forest plots in a meaningful and clinically relevant way. 

You will also learn how to spot common pitfalls, recognise misleading claims or visuals, and assess whether a result is statistically significant and clinically important.

Finally, you will gain practical tools to communicate data responsibly.

If you want to strengthen your ability to evaluate evidence and translate statistics into credible Medical Affairs insights, this course is a must-attend!
 


THE EXPERT

Stef De Reys, PhD, is a medical statistics expert with over 30 years of experience applying biostatistics across research, Medical Affairs, and commercial functions. 

  • As an independent consultant, Stef helps biotech and life science companies use data to optimise processes and make evidence-based strategic decisions. 

  • He has held global Medical Affairs positions for international companies, where he used data and analytics to improve Medical Affairs operations, from evidence-generation planning to field medical strategy and performance measurement.

  • Stef is known for his ability to translate complex statistical outcomes into simple, clinically meaningful messages, making data feel less abstract and more directly applicable to daily practice and long-term strategy.
     


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for Medical Affairs professionals, including MSLs, Medical Managers, Medical Information specialists and others who work with clinical evidence and want greater confidence in interpreting and communicating statistics.

Through expert-led teaching, real-life cases, and interactive group exercises, you will learn how to interpret clinical trial results, survival curves, and meta-analyses, and how to communicate findings in a fair-balanced, compliant, and audience-appropriate way. The sessions include practical examples, hands-on interpretation tasks, and peer discussions to help you build skills you can apply immediately in your daily Medical Affairs role. 

If you are a consultant, please contact Annelies Swaan, who will check with the faculty whether you can attend. 

 

  1. How to recognise and avoid common pitfalls in statistical thinking that lead to incorrect interpretation of data.

  2. How to interpret key statistical outputs in clinical trials, including p-values, confidence intervals, hypothesis testing, Type I/II errors, and safety data (AE/SAE tables) from different study designs.

  3. How to interpret survival analyses, including Kaplan–Meier curves, hazard ratios, proportional hazards, and crossing curves.

  4. How to interpret meta-analyses, including forest plots, heterogeneity, and the statistical limits of meta-analysis.

  5. How to communicate statistical findings clearly, fairly, and compliantly, including recognising spin, avoiding misleading visuals, tailoring messages and applying good-practice templates.

Course agenda

 

 

Welcome & General Introduction  (~15 min)
The Importance of Proper Statistical Thinking and Interpretation in Medical Affairs  (~30 min)
  • Why correct statistical interpretation is essential in Medical Affairs: ensuring scientific credibility, fair-balanced communication, and informed decision-making
  • Common real-world challenges and pitfalls that make statistical results difficult to interpret correctly in daily Medical Affairs practice
  • Real-world examples of common violations of assumptions and of correct interpretation of statistical results
Reading Clinical Trial Results: From Statistically Significant to Clinically Relevant  (~1 h 15 min)
  • How to recognise study designs and start a structured statistical interpretation 
  • Overview of different data types and measurement scales
  • Statistical significance vs clinical relevance when assessing real-world impact:
    • Why confidence intervals often matter more than p-values for the interpretation of certainty and effect size
    • How hypothesis testing is used to decide whether an observed difference in a trial is likely real or due to chance 
    • Type I and Type II errors: The basics of false positives and false negatives in trials, and how these uncertainties influence interpretation
  • Basics of interpreting safety and tolerability data:
    • Understanding key risk indicators in clinical trials and what they mean for patient benefit
    • How to read Adverse Event and Serious Adverse Event tables like a pro
    • Group exercise: In groups, attendees will interpret a safety-summary slide. Findings will be discussed in plenary
  • “Do try this at home”: examples of common interpretation problems and practical solutions
Survival Curves Demystified: What They Mean for Patient Outcomes (~1 h 30 min)
  • How to read Kaplan–Meier plots correctly: understanding events, median OS/PFS, time to first AE, censoring
  • Clear explanation of what hazard ratios represent, when the proportional-hazards assumption matters, and how crossing curves affect the interpretation of treatment benefit
  • Three practical cases from different therapeutic fields: 
    • How to interpret Kaplan–Meier curves and forest plots
    • What you can and cannot legitimately conclude 
Lunch Break
Making Sense of Meta-Analysis (~1 h 30 min)
  • Learn what you can and cannot infer from pooled data
  • Understand heterogeneity conceptually (no formulas) 
  • Checklist: five questions before using meta-analysis in a slide deck
  • Group exercise: Attendees work in groups to review a forest plot and assess what the pooled evidence does and does not support, followed by a plenary debrief 
Fair-Balanced Communication & Critical Interpretation of Clinical Data (~1 h 15 min)
  • How to translate trial data into fair and balanced statements that communicate meaningful insights to stakeholders
  • Data visualisation best practices: 
    • Do’s & don’ts in creating clear, non-misleading graphs, tables and charts
    • How to recognise cherry-picking and visual manipulation
  • Spotting spin and misleading statistics: training the eye to spot overstatements or misinterpretations in competitor data or press releases
  • Clear, practice-oriented examples of how to keep statements compliant, non-promotional, and aligned with the label in everyday Medical Affairs communication
  • How to tailor your message to your audience:
    • Communicating statistical findings to a lay patient audience
    • Communicating statistical findings to a data-KOL
  • Practical templates and ready-to-use checklists to help create clear, accurate, and non-misleading charts for Medical Affairs communication 
Quiz, Wrap-Up & Q&A (~45 min)
  • 10-question interpretation quiz (no formulas)
  • “What I take away” summary per module
  • Open Q&A

 

Download Brochure

 

Complete the form below to download the course brochure and discover the full agenda, what you will learn, who you will learn from, and what past participants have to say.

 

UPCOMING DATES & FORMATS - FEES

11 March 2026

Live online

Early bird € 1 570

(until 06/02/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Dates & Locations

11 March 2026

Live online

Register