Biostatistician / Data Manager V&V (m / f / d)

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)

Aufgaben

• 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

Please be advised that a valid work permit for Germany is required for non-EU citizens. Unfortunately, applications without a valid work permit and sufficient German language skills may not be considered.