Senior Clinical Biostatistician

At Radiometer, we believe that life is not something to be taken for granted—it’s our ultimate mission. When the unexpected happens, our technologies empower healthcare professionals to make confident, timely diagnostic decisions that improve patient outcomes. This shared purpose unites our global team of 4,000+ colleagues across roles and regions.

Creating meaningful innovations doesn’t happen overnight. It takes dedication, curiosity, and a deep desire to make a difference. At Radiometer, you’ll find the opportunity to grow, learn, and build a uniquely diverse and impactful career. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses

We are looking for a Senior Clinical Biostatistician to join our team. This position is part of Clinical & Medical Affairs function located in Brønshøj, Copenhagen. This is an onsite role.

As a Senior Clinical Biostatistician, you will be responsible for all statistical aspects of designing, statistical programming, analyzing, and reporting of clinical studies globally in a range of different product areas throughout the product lifecycle in a global environment.

You will be a part of a team of 10 colleagues in the Clinical Data Science team and report to the Director of Clinical Data Science. The team’s primary focus is on data management, clinical IT and biostatistics. If you thrive in a highly analytical role and want to work to build a world-class clinical data analysis organization — read on.

In this role, you will have the opportunity to:

• Consult with the project teams and apply statistical expertise to ensure scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies and project teams.

• Provide statistical sample size calculations and development of the statistical analysis plan (SAP) for clinical studies and complete SAP throughout lifecycle of the study.

• Develop statistical programs to perform analyses and prepare data displays by developing standards to ensure quality in standard work incl. dataset structures, macros, and programs for analyses.

• Contribute to ad hoc explorative analyses for internal understanding, collaborate to generate health economics evidence and publications.

• Represent Clinical Data Science in cross-functional study teams and proactive contribute to biostatistical advice in line with guidelines and state-of-the art methodologies.

The essential requirements of the job include:

• At minimum five years’ experience in biostatistics in medical device, pharmaceutical and/or academia

• Experience with in vitro diagnostic (IVD) and/or medical device (MD) products

• Proven experience in developing statistical analyses plans and analyzing complex clinical study data sets in a clinical affairs organization

• Demonstrated understanding of regulatory requirements for data analyses (e.g.: CLSI) for submissions

• Demonstrated proficiency of advanced statistical analysis software and tools ((E.g. SAS, Minitab, R, SPSS)

• Capable of participating in cross-functional projects and managing timelines across multiple projects. Experience with proactive planning, analyzing, and reporting of clinical studies for clinical diagnostics and/or medical devices e.g., precision, stability, and clinical sensitivity specificity studies.

• Able to communicate fluently on a scientific and layman level in English, oral and written

It would be a plus if you also possess previous experience in:

• Experience with Blood Gas, Transcutaneous Monitoring, Immunoassays or Sampler for Blood Gas testing

Application

We review applications on an ongoing basis and invite candidates to interview ongoing. Therefore, we encourage you to apply as soon as possible.

Please note that due to the summer holiday period, our response times may be slightly longer than usual. We appreciate your patience and understanding, and we will get back to you as soon as we can.

We look forward to receiving your application.