Job
In this position, you analyze performance evaluation and stability study data, create data analysis templates, and support analytical evaluations to facilitate data-driven decision-making.
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Your role in the team
- Support of the V&V team in performance evaluation and stability studies as well as their data analysis and documentation.
- Application of statistical methods for data analysis.
- Creation and validation of data analysis templates.
- Support for data-driven decision-making processes.
- Analysis of internal and external performance data using statistical tools.
- Creation of protocols for analytical evaluation.
- Support in the Post-Market Performance Follow-up Process (PMPF).
- Preparation of reports on performance studies.
- Participation in the development of templates for clinical evidence requirements.
Our expectations of you
Education
- Completed master's degree in Biostatistics, Statistics, Mathematics, or a related field; a scientific background (e.g., Biology or Chemistry) is advantageous. A PhD is desirable.
Qualifications
- Very good knowledge of statistical methods and procedures.
- Good understanding of complex performance and study data.
- Basic understanding of relevant standards and regulatory requirements (e.g., ISO, CLSI, 21 CFR).
- Very good spoken and written English skills.
Experience
- Initial professional experience in a diagnostic or pharmaceutical environment.
- Experience in writing technical and scientific documents; ideally, experience in preparing documentation for regulatory agencies (e.g., Notified Bodies, FDA, or other authorities).
What we offer
- Permanent contract in a rapidly growing company.
- Crisis-proof workplace.
- Flexible working hours.
- No shift work.
- The annual salary typically ranges between €50,000 and €65,000 gross.
- Monthly subsidy of up to €200 for nursery and kindergarten.
- Free parking spaces directly at the company premises.
- Individual development and training opportunities.
- Attractive package of health and social benefits (e.g., subsidy for computer glasses or flu vaccination).
- Free Employee Assistance Program for emotional and practical well-being.
- Employer subsidy of 30% for private retirement provision.
- Daily freshly cooked meals from regional ingredients - with meal allowance.
- Complimentary beverages: coffee, tea, hot chocolate, and water.
- Exclusive employee discounts at well-known brands.
- Anniversary rewards as a token of appreciation for your loyalty.
Benefits
Work-Life-Integration
Topics you will work on
Job locations
About your employer
Founded in 1988 in Mainz, Orgentec Diagnostika GmbH is a leading company in laboratory diagnostics, developing and distributing innovative test systems for autoimmune diagnostics and infection serology.
- Established Company
- Onsite
- Healthcare, Social Sector
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