Dr. Bernd-Wolfgang Igl (Bayer AG)
Dose-response analysis is a central part in statistical evaluation of toxicological bioassays. Two approaches are used: simultaneous testing of order-restricted multiple contrasts and regression-based modeling. The first one considers the DOSE qualitatively, i.e. as randomized factor whereas the second assumes DOSE as quantitative covariate (in bioassays commonly for grouped dose levels). Both approaches are demonstrated by means of real data examples where robustness, e.g. against downturn effects is discussed. Moreover, a new approach is explained, where DOSE is jointly considered both quali- and quantitatively.
The recent p-value controversy is discussed from the perspective of regulatory toxicology where first confidence intervals for specific selected effect sizes are recommended. Secondly, the inclusion of individual data points within or without a prediction interval is proposed as an alternative to common-used null-hypothesis significance tests. The prediction intervals are defined for any single future value of a group with sample size n_i using the controls of multiple historical bioassays. The within- and between assay variance is considered by a mixed effect model.
Finally, the question will be discussed why the proof of safety („be safe in negative results“) is not widely used in routine up to now.
The “third main set” of statistics is: software must be available. And therefore all methods are demonstrated using //R-//CRAN packages.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
This is a free webinar on Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
