Job Details

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Radiometer, one of Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Radiometer, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, youll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the worlds most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

As part of Danahers Clinical Center of Excellence, the Senior Biostatistician is responsible for providing statistical support for clinical study design, analysis, and reporting for registration/pre-market approval (CE-IVD and US-IVD) of qualitative and quantitative IVD molecular assays for infectious disease, hematology, and oncology applications across Danaher Diagnostics Op Cos. This position will be point of contact for regulatory questions pertaining to analysis.

This position reports to the Senior Director, Biostatistics and is part of the Bioinformatics team within Danaher Clinical Center of Excellence located in the USA and will be fully remote.

In This Role, You Will Have The Opportunity To

• Provide end-to-end statistical analysis support for IVD product life cycle development through creation and verification of multiplex biomarker signatures in infectious disease, blood diagnostics, and oncology to regulatory submission. This can involve the application of various statistical methodologies (general linear modeling, survival analysis, multivariate classification tools, etc.).
• Provide statistical input in clinical study designs including sample size estimates using OC and power curves while ensuring the team understands statistical risks of the study design and sampling plan used
• Author statistical section for clinical protocols, statistical analysis plans, statistical analysis reports, and clinical study reports submitted to FDA or other regulatory agencies.
• Review and update standard operating procedures for relevant functions, provide statistical training/education programs to other teams as needed and support audits of clinical data.
• Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity study

The Essential Requirements Of The Job Include

• Bachelors Degree in Statistics or Biostatistics with 10+ years of experience OR MS in Statistics or Biostatistics with 10+ years of experience OR PhD in Statistics or Biostatistics with 5+ years of experience
• Work experience as a lead statistician in analysis and reporting of IVD, medical devices, and imaging clinical studies in a regulated environment
• Knowledge of FDA, CE-IVDR, WHO and other diagnostics industry guidelines. The successful candidate will need to stay current on statistical standards (e.g. CLSI, etc.) and trends in the IVD industry as well as FDA and other regulatory agency guidelines.
• Relevant knowledge and usage of SAS, Excel, Minitab, Python or R with excellent oral and written communication skills
• Ability to convert business, scientific, and engineering concepts into clear mathematical/ statistical concepts and the ability to express them in ways understandable to non-statisticians

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

• IVD regulatory submissions and regulatory interactions with FDA CDRH and CE.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Travel less than 5%

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job.

The annual salary range for this role is $114,700 - $157,700. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-###-#### or ...@danaher.com.