All phases of pharmaceutical clinical development including late phase observational trials and trials based on real world data/registry data
Study design, sample size calculations, estimands
Protocol input, statistical analysis plan, planned and post-hoc analyses
Submissions, Questions and Answers, regulatory meetings
Small early-stage biotech companies as well as large international pharmaceutical organizations within a variety of different disease areas. I also have experience within the medical device and diagnostic test areas
Research projects at all stages, including first- and co-authoring numerous publications, among others several projects using Danish registries
Epidemiology
Data safety monitoring board member
Observational studies, post-approval studies, and registry studies
For more details, please see my CV.