CMC Biostatistician

With extensive experience in biostatistics and data analysis, the candidate specializes in biopharmaceutical drug development and regulatory filings, contributing to successful BLAs

An expert in design of experiments and statistical analysis, the candidate provides global training and consulting services, significantly improving bioassays

Proficient in developing machine learning models and data analysis software, the candidate has a strong background in chemometrics and bioinformatics, enhancing diagnostics and process optimization

Fluent in R and Python programming, the candidate possesses advanced skills in regression modeling and data pipeline management, ensuring data integrity in biopharmaceutical settings

Product ownership for our biostatistical services provided to client project teams including establishment of tailored design of experiments, data processing, evaluation, and visualization (incl. R-programming and code review, subject matter expert support in project meetings)

Performance of shelf-life predictions based on different methodologies including linear and multiple regression or advanced kinetic modeling

 Ownership for data pipelines ensuring integrity of data and efficiency of workflows

 Prioritization and management of the TFS ticket system 

Data base migration (incl. programming in C# and code review)

Provision of scientific advice to support commercial activities incl. digital marketing and project acquisition 

Supervision of academic thesis 

Increasing client’s visibility by co-authoring scientific publications or representing client at conferences 

Ownership for tailored trainings on Biostatistics for different departments

Lead statistician / data scientist responsible for developing a novel cancer test based on machine learning on high-dimensional microarray data and for fulfilling the regulatory requirements including communication with the U.S. Food and Drug Administration

Responsible for all machine learning prediction models developed in the R&D division

Responsible for all study designs and statistical analysis plans in the R&D division

Leading a team with 2 Ph.D. level bioinformaticians

Primarily involved in a collaborative network with Denmark’s leading pharmaceutical and food industry

Providing courses in advanced chemometrics/bioinformatics for industry

Development of new data science methodologies

Responsible involvement in development of novel leukemia diagnostics using machine learning on high-dimensional microarray data, including supervision of study design, development of a new data pre-processing, feature selection and implementation of a fully automatic prediction algorithm

Collaboration on gene expression analysis of microdissected lung cancer specimens

Development of various “disease pattern recognition” systems for client, i.e. high-throughput diagnostics based on metabolomic infrared fingerprinting, including the first ante-mortem BSE test

Heading the German competence centre within European network of excellence in chemometrics (VICIM)