After my internship in 2003 in the team Non-Clinical Statistics Ingelheim (NCSI) at Boehringer Ingelheim I decided to become a statistician. I became master student, PhD student and statistical consultant at NCSI until I joined the team as internal employee after completion of my dissertation. I am supporting the CMC (Chemistry, Manufacturing and Control) area with
- planning and evaluation of all kind of univariate and multivariate equivalence studies,
- risk analyses,
- process validation (PPQ and CPV),
- statistical training for non-statisticians,
- stability analyses,
among others.
In my academic career I specialized in equivalence procedures which are needed in pharmaceutical development, production and quality control, e.g. in the context of scale-ups and post-approval changes. One of my major tasks during the last years was developing, publishing and promotion of innovative statistical methods for equivalence analyses of dissolution profiles. I discussed the methods with statisticians of regulatory agencies, presented at workshops and conferences, organized and led roundtable discussions on the dissolution profile topic and published software implementations in SAS and R. I am author of the R packages T2EQ, EDNE.EQ and SE.EQ available on CRAN.
I am a passionate scientist, having published several papers as single or main author and being a reviewer for Biometrics, Journal of Applied Statistics, among others. But as well it is a matter of course to me to visualize, interpret and explain in easy words statistical methods and results to interdisciplinary project teams and to find the balance between scientific and practical needs. In presentations and interactions with colleagues, a statistician should particularly focus on a didactical concept and the statistical level should be custom-made to the respective audience. Once upon a time, I wanted to become a teacher. I am now very happy that as a statistician, I am both, a scientist and a teacher.
In my free time, I like to do sports (hiking, bouldering, wakeboard) and to spend time with my family.

With over 20 years’ experience in the pharmaceutical industry, working primarily in R&D, including support of many regulatory submissions which have successfully transitioned into commercial products.
Leading the statistical efforts to support the Chemistry, Manufacturing and Control sections of these submissions, replies to regulatory questions, supplementary submissions and manufacturing variations.