Biostatistician / Statistician

Job description

The job


The (Bio)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. 

Job requirements

Personal skills


  • 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.
Profile and competences


  • Requires a master's degree or PhD in mathematics/ statistics
  • At least 4 years of experience in the field or in a related area
  • You have a good working knowledge of statistics packages like “SAS”, “R”, “SPSS”, “MINITAB” etc
  • 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. Likely maximum 5% of your time.