With an experienced team of 70 employees located at the Roche Diagnostics sites Penzberg, Indianapolis and Mannheim we support statistical analysis, data management, data sciences, software engineering and process support.
You apply adequate statistical procedures to all aspects of diagnostic projects (e.g. assay development, measurement method comparison, biomarker cut-off determination and validation, regulatory submission support)
You are responsible for planning of clinical and analytical studies, writing of statistical analysis plans, programming of statistical analyses, evaluation of study results and creation of analysis reports, validation of study results as well as presentation of results and statistical knowledge internally and to external partners
You are specifically responsible for the statistical support of companion diagnostics / personalized health care projects. This includes support of pharmaceutical trials (Phase 1- Phase 3) of internal and external partners with biomarkers (e.g. cut-off decision, bridging studies)
You ensure the quality of the acquired data and support submissions of study results to regulatory authorities
Additionally, you apply univariate and multivariate statistical procedures, potentially machine learning approaches, for the evaluation of new predictive and prognostic biomarkers
You are willing to learn and implement new biostatistical methods
You work in an interdisciplinary environment in close contact with assay developers, study managers, medical doctors, regulatory affairs and data managers
Our ideal candidate
University degree in (bio)statistics or related subject (e.g. bioinformatics, mathematics, physics) with substantial experience in statistics; preferably with Ph.D.
Preferably, 1-2 years of (non-academic) work experience in biostatistics
Expertise in biostatistical methods, including aspects of univariate and multivariate data analysis and ideally statistical procedures in diagnostics (method comparison, ROC analysis, longitudinal data analysis)
Experience in design, analysis and evaluation of clinical and non-clinical studies, ideally personalized health care studies and biomarker studies
Excellent knowledge of R and ideally of SAS and Latex
Enthusiasm to learn and implement new statistical methodology, excellent analytical skills
Excellent communication and documentation skills and eager to work in international and interdisciplinary teams
Basic knowledge in biochemistry and medical diagnostic
English: fluent in speaking and writing
Willing to travel
This position is limited to 3 years.
To make the application process as comfortable as possible for you please add only your updated CV. References and certificates are not required at this stage.
We look forward receiving your application!
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Roche is an equal opportunity employer.Research & Development, Research & Development > Biometrics