Beschreibung
Senior Non-Clinical StatisticianTasks:
• You are responsible for the statistical support in the area of Animal Health including the related pivotal studies for submission and vaccine development studies.
• The tasks include study planning, preparation of the statistical study protol, data evaluation and creation of the statistical study report as well as active contribution to related publications.
• You provide statistical expertise in the area of CMC, e.g. for validations of analytical procedures, process validations, continued process verifications (CPV), stability studies, transfers of analytical methods, out-of-specification evaluations and assessments of testing specification procedures and conduct statistical trainings for the applicants in the related fields.
Requirements:
• Degree in Statistics or Mathematics (MSc/PhD)
• Working experience as Senior Non-Clinical Statistician in area of Animal Health and/or Chemical, Manufacturing & Control (CMC) for several years and in-depth knowledge of related regulatory guidelines and requirements Practical experience in the analysis of complex data and excellent knowledge of statistical software solutions, preferably SAS
• Excellent presentation, communication and team work skills, high flexibility, readiness, ability to work under pressure
• Fluent in spoken and written English - basic German