Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician
Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects
Provides statistical input in clinical development discussions, and usage of AI and ML approaches
Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects
Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms
Experience with RNA, olink and other biomarker data handling experience
Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results
Works independently at routine and complex statistical questions, modeling and tasks
Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments
Qualifications
PhD or MSc in Biostatistics, Statistics or Mathematics, or related field
Strong communication and interpersonal skills
Ability to work independently as well as collaboratively, as required
Minimal supervision required
Usage of AI and ML approaches
Previous experience in independently leading biomarker study mandatory
Previous clinical trial experience, industry experience is preferred
Strong knowledge on Biomarker evaluation, esp. In immunology and infections, type I diabetes, relevant parameters and underlying biology
Good knowledge of statistical programming languages including R (Bioconductor package and other relevant R packages for genetic data), Python
Analysis of high-dimensional data
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