Senior Biostatistician

In our line of work, life isnât a given - itâs the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world weâre located. Creating impactful innovations like ours, doesnât happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.  

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges.  

The Senior Biostatistician for Radiometer is 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.

This position is part of Clinical & Medical Affairs function located in Brønshøj, København. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of a team of nine colleagues in Clinical Evidence, Analytics & Reporting and report to the Senior Manager. The teamâs primary focus is on data management, data analysis and biostatistics. If you thrive in a highly analytical role and want to work to build a world-class clinical data analysis organizationâread 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 support to assist with 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 CLEAR 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:

• Five yearsâ experience in biostatistics in medical device, pharmaceutical and/or academia

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

• Deep knowledge about design of clinical trial, statistical methodologies, statistical programming using SAS, and interpretation and presentation of complex statistical results. 

• 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:

• R programming.

• Power BI report development.

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

A hybrid way of working:
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. 

Application:
We continuously assess candidates and invite for interviews, so please donât hesitate to submit your CV/resume and cover letter. If you have questions, feel free to contact Senior Manager, Clinical & Medical Affairs Carsten Sass on tel. 31357556. Thank you for your interest.
 

Danaher

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.