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/w/d)
Main Tasks:
- Support the V&V team in performance evaluation and stability studies and their data analysis and documentation by:
- Applying statistical methodologies to data
- Creation and validation of data analyzation sheets
- Support data-driven decisions
- Data evaluation (internal/external performance data) by using statistical tools
- Drafting analytical evaluation protocols
- Preparation of performance study reports
- Support the Post-marked Performance Follow-up process
- Support the creation of templates for Clinical Evidence requirements
Skills:
- Master`s degree in Biostatistics, Statistics, Mathematics or related field; background with knowledge in Science (Biology or Chemistry) is a plus
- Advanced graduate degree (PhD) is a plus
- strong understanding of statistical methodologies and techniques
- Experience in statistical tools for data analysis
- Understanding of complex performance data
- Experience 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)
- Careful, accurate and responsible way of working
- Good documentation practice
- Confident in the use of MS-Office, especially Excel
Benefits :
- Permanent employment contract
- A crisis-proof job with an attractive income
- 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
- Car park directly at the company
We look forward to receiving your application (cover letter, CV, references) by e-mail to jobs@orgentec.com. Please state your salary expectations and a possible starting date.
