Job Description
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 Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's 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, you'll 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 world's 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 Danaher's 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:
- Bachelor's 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:
Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.
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. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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.
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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.
The U.S. EEO posters are available here.
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: [click to reveal phone number]1-202-419-7762 or [click to reveal email address] applyassistance@danaher.com .
Job Tags
Full time, Work experience placement, Immediate start, Remote work, Work from home, Flexible hours,