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Staburo Academy

We love to share our statistical expertise and offer a wide range of specific training programs.

Expertise & Solutions

Quality

Staburo Academy

Our Courses

All courses can be tailored to your company’s needs whether for small or large groups, individual consultancy, or as a guest speaker at your in-house seminar.

Our coaches are statisticians and subject matter experts with a broad practical knowledge and teaching experience.
The trainings can range from basic to state-of-the-art statistical topics.

Estimands Workshop

About the Course

The estimand framework (ICH E9(R1)) is inherently collaborative.

Estimands shift the focus from statistical methods alone to a shared framework for designing, conducting, analysing, and interpreting clinical trials, cross-functionally.

This is why our biostatisticians have partnered with regulatory medical writers. Together, they have designed a workshop tailored to your needs.

Topics

Level 1 – The Big Picture
Participants will learn how estimands affect budgets and timelines, helping them plan strategically and save sponsors time and money.
Level 2 – Practical Utility
Participants will learn how medical writers, clinicians, and statisticians work together to embed estimands into study planning from the start. The workshop will outline a practical process for developing estimands in the CSP and for reporting them clearly in the CSR and trial registries, aligned with the statistical analysis plan. Detailed statistical methods will not be covered.
Level 3 – Deep Dive
Participants will gain in-depth knowledge of the estimand framework. The workshop will use examples from different study phases and therapeutic areas to explore how to construct estimands, handle intercurrent events, address their impact on trial analyses (including missing data and sensitivity analyses), and more.

Each level includes practical and relevant exercises.

Target Audience

Level 1: for business development, proposals, senior managers
Level 2: For medical writers & clinicians
Level 3: For statisticians & trial designers

Find all details and as well as information about our instructors here.

Clinical Trial Disclosure & Transparency

For study managers in smaller companies and in academia it can be hard to keep up with the constantly evolving landscape of regulations.
This workshop is addressed (but not restricted) to professionals who are interested in or have to handle clinical trial and document disclosure.

Topics

Regulations in the US: FDAAA 801 and the Final Rule
Regulations in the EU: CT Regulation 536/2014 (CTIS) and Clinical Trial Directive 2001/20 (EudraCT)
Designing a ‘disclosure ready’ study
Practical training on data entry into Clinicaltrials.gov and EudraCT/CTIS
Document disclosure (redaction of PPD and CCI, deferral)

Introduction to Statistics

This course is designed for anyone wishing to understand basic statistical techniques thoroughly, e.g.: Clinical Research Associates, Project Managers, Team Managers, Principal Investigators, Medical Professionals, CMC Managers, Regulatory Affairs Managers.

Topics

Descriptive statistics: How to summarise data
Exploration of data
Graphics and presentation of data
Assessing significant differences between groups
Investigation of associations and correlations
Basic trend analysis

Advanced Statistical Methods

This follow-up course on our “Introduction to Statistics”-course is designed for advanced members with basic knowledge of statistics and programming skills in R.

Topics

Advanced/generalised regression models
Survival analysis (survival data structure, Kaplan-Meier estimator, Log-rank test,
Cox proportional hazards model)
Meta-analysis (idea/concept, statistical methods, forest plots, challenges and possible solutions, network meta-analysis)

Machine Learning & High-Dimensional Methods

Phrases like “data mining” and “big data” are omnipresent nowadays. Knowledge of the most state-of-the-art machine learning techniques is an important instrument, not only for the ability to perform the appropriate statistical analyses in various settings, but also for a better understanding and interpreting of study results.
This course is designed for advanced members with basic knowledge of statistics and programming skills in R. It is designed as a 2-day course.

Topics

Introduction to high dimensionality and machine learning
PCA and LASSO
Principal component analysis
Support vector machines
K-means
Decision Trees / Random Forests
Boosting
SVMs
Neural Networks / AI

Introduction to R

This course is designed for anyone wishing to understand basic statistical techniques thoroughly, e.g.: Clinical Research Associates, Project Managers, Team Managers, Principal Investigators, Medical Professionals, CMC Managers, Regulatory Affairs Managers.