ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses, France, ORGENTEC supplies medical laboratories in over 100 countries with highly specialised and innovative devices and test kits. Our company is characterised by steady and sustainable growth in an internationally oriented, future-oriented business field.
To strengthen our team at the Mainz site, we are looking for a
Biostatistician / Data Manager V&V (m/f/d)
Support the V&V team in performance evaluation, stability studies, data analysis and documentation by:
Applying statistical methodologies to data
Creating and validating data analysis sheets
Supporting data-driven decisions
Evaluating data (internal / external performance data) with statistical tools
Drafting analytical evaluation protocols
Preparing performance study reports
Supporting the post-marked performance follow-up process
Supporting the creation of templates for clinical evidence requirements
Master's degree in Biostatistics, Statistics, Mathematics or a related field; scientific knowledge (biology or chemistry) is a plus
Advanced graduate degree (PhD) is a plus
Strong understanding of statistical methodologies and techniques
Experience in statistical data analysis tools
Understanding of complex performance data
Expertise in technical and scientific writing; experience in writing for regulatory audiences such as notified Bodies, FDA or other authorities is a plus
Understanding of standard landscape (ISO, CLSI, 21CFR)
Ability to work in a team
Careful, accurate and responsible way of working
Good documentation practice
Confident in the use of MS Office, especially Excel
Permanent employment contract
Crisis-proof job with an attractive income
Annual salary review
Flexible working hours
Individualised employee development and training
Attractive package of health and social benefits (e.g., subsidised computer glasses, flu vaccination, employer contribution of 30% to private pension scheme)
Employer subsidy for the canteen, free drinks
Crèche and kindergarten allowance (max. 200€)
Employee discounts with well-known brands
Anniversary bonus
Car park directly on site