Nuvisan
Wegenerstraße 13, 89231 Neu-Ulm, Germany
TASKS
Planning, execution and documentation of statistical analyses for phase I-II clinical trials
Input for the study synopsis and study protocol
Sample size planning and randomization
Creation and review of statistical analysis plans
SAS programming and validation of statistical analyses and datasets
Input for the study report
Preparation of statistical reports
Close collaboration with Clinical Data Management, Medical Writing, Project Management and other interdisciplinary departments
Ensuring compliance with applicable quality, compliance and regulatory requirements.
Creation of SOPs
QUALIFICATIONS
Completed studies in biostatistics, statistics, mathematics, bioinformatics, epidemiology or a comparable field
Professional experience in biostatistics, preferably in the field of clinical trials, in the pharmaceutical industry or at a CRO
Excellent knowledge of statistical methods, especially in the evaluation of clinical or observational...