Gaston Geenslaan 1 Leuven Belgium
Quality and Regulatory
miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules. Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves. There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers.
The Statistician leads statistical support and analysis for all of the quality and regulatory activities within the company. This includes sampling strategies, investigation plans, product performance data analysis, clinical trials, stability trials and validations.
She/He will need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended.
All activities meet the requirements of ISO 13485 and 21 CFR 820, and is a champion of Design controls and data quality.
Preparation of analysis plans and creation of detailed specifications for data analysis, consistency checks, tables, and figures to present complex data in understandable formats
Communicates with team members regarding statistical analysis issues. Interpretation, analysis and creation of statistical sections of study reports.
Familiar with a variety of the statistical concepts, practices, and procedures.
Relies on extensive experience and judgment to plan and accomplish goals. Performs a wide variety of tasks.
Direction of the work of others. Thinks creatively.
- Requires a master's degree/Ph.D in mathematics/ statistics and at least 4 years of experience in the field or in a related area
- Prior Quality experience in the IVD industry or the medical device industry. Clinical trial experience is desirable. Knowledge of Quality System standards/regulations (ISO 13485, 21 CFR 820).
- Fluent English speaker. Able to travel if required.
- Works well in a team but equally can operate autonomously with personal accountability for objectives
- Ability to analyze and interpret technical procedures and governmental regulations.
- Ability to create technical reports, business correspondence, technical procedures, as well as, administrative procedures.
- Ethical and high integrity toward data and mathematical conclusions.
- Ability to present proposals, data, and issues to miDiagnostics personnel at all levels.
- Aptitude for problem solving. Solutions must be thorough, practical, and consistent with organization objectives.
- Ability to represent the team in frequent cross-functional interactions with regulators, subcontractors, and/or vendors.
- Ability to determine and develop technical solutions to a wide range of difficult problems.
- Full-time job at a fast-growing and ambitious start-up in the biotech industry
- Market competitive salary and benefits package
- miDiagnostics is an international-oriented company with close connections to two world class research institutions (imec and Johns Hopkins University)
- Opportunity to grow in a new and exciting cutting-edge field in point-of-care diagnostics
Interested? Please apply by e-mail to email@example.com (cv and motivation letter) with reference to this opportunity