Job
- Level
- Erfahren
- Job Feld
- Data
- Anstellung
- Vollzeit
- Vertragsart
- Befristetes Dienstverhältnis
- Ort
- Mainz
- Arbeitsmodell
- Onsite
Job Zusammenfassung
In dieser Rolle unterstützt du das R&D-Team bei der analytischen und klinischen Evaluierung von Produkten und der Datenanalyse durch die Erstellung von Evaluierungsprotokollen und Berichten sowie die Anwendung statistischer Tools.
Job Technologien
Deine Rolle im Team
- 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 external collaboration partner
Unsere Erwartungen an dich
Ausbildung
- Master's degree in biology, biotechnology, biochemistry, or similar; advanced graduate degree (PhD) is a plus
Qualifikationen
- Strong analytical and strong quality management thinking
- Interest and understanding of regulatory landscape (IVDR, ISO, CLSI, 21CFR)
- Understanding of complex performance data with excellent data presentation skills
- 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
Erfahrung
- Experience in technical and scientific writing for regulatory audiences such as Notified Bodies, FDA or other authorities is a plus
- Experience in statistical tools for data analysis, especially Excel, additional tools are a plus
Unser Angebot
- 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
- Crèche and kindergarten allowance (max. €200)
- Employee discounts with well-known brands
- Anniversary bonus
- Car park directly at the company
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
Orgentec Diagnostika GmbH
Die Orgentec Diagnostika GmbH, gegründet 1988 in Mainz, ist ein führendes Unternehmen im Bereich der Labor-Diagnostik, das innovative Testsysteme für Autoimmundiagnostik und Infektionsserologie entwickelt und vertreibt.
Description
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Onsite
- Branche
- Gesundheitswesen, Soziales
Study and Data Scientist R & D
- Ort
- Mainz
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
