Study and Data Scientist (m/f/d) Research and Development

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 specialized and innovative devices and test kits. Our company is characterized by steady and sustainable growth in an internationally orientedand future-focused business field.

To strengthen our team at the Mainz site, we are looking for a

Study and Data Scientist (m/f/d) R&D
full-time, fixed-term

Support the R&D team in analytical and clinical performance evaluation of products and stability studies and their data analysis, and documentation by:

• Preparation of analytical evaluation protocols
• Data evaluation (internal / external performance data) by using statistical tools
• Preparation of performance study reports
• Support the post-marked performance follow-up process
• Support the creation of templates for Clinical Evidence requirements
• Drive projects across various global Sebia sites and work with an external collaboration partner

• Master`s degree in biology, biotechnology, biochemistry, or similar; an advanced graduate degree (PhD) is a plus
• Experience in technical and scientific writing for regulatory audiences such as notified bodies, FDA or other authorities is a plus
• Strong analytical and excellent quality management thinking
• Interest and understanding of regulatory landscape (IVDR, ISO, CLSI, 21CFR)
• Understanding of complex performance data with excellent data presentation skills
• Experience in statistical tools for data analysis, especially Excel, additional tools are a plus
• Enjoy working in a team
• Careful, accurate and responsible way of working
• Good documentation practice
• Confident in the use of MS Office
• Fluent in English, German is a plus

• Fixed-term employment contract
• A 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
• Childcare and kindergarten allowance (up to € 200)
• Employee discounts with well-known brands
• Anniversary bonus
• Car park directly at the company

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