Description

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

At Leica Biosystems, 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 Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Biostatistician- R&D is responsible working cross-functionally with R&D, Clinical, Regulatory, and Marketing teams to support the design of robust studies, analyze data, and interpret results that inform the development and successful launch of new products.

This position reports to the R&D Manager and is part of the R&D team located in Newcastle upon Tyne and will be an on-site role.

In this role, you will have the opportunity to:

• Provide statistical leadership and guidance throughout the new product development lifecycle, from concept to launch.
• Design statistically sound studies for analytical performance evaluation, including precision, specificity, and reproducibility.
• Collaborate with assay development teams (R&D) to define acceptance criteria and specifications based on statistical rationale and product requirements.
• Translate complex statistical data sets into clear, actionable insights for technical and non-technical stakeholders.
• Provide input on design control documentation, including risk management, design inputs/outputs, and verification protocols.
• Author and review regulatory submission documents, including statistical reports for FDA (510(k), De Novo, PMA) and EU IVDR Technical Files.

The essential requirements of the job include:

• Strong understanding of analytical and clinical performance evaluation requirements for IVD devices.
• Experience of applying biostatistics in an R&D or regulated industry environment (e.g., medical devices, pharmaceuticals, diagnostics).
• Strong knowledge of statistical methods used in product development and clinical research.
• Proficiency with statistical software, Expertise in SAS is required. Familiarity with MS Access and Visual Basic would-be a plus.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• % - Travel expectations for this role are Low (<5%)

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

• Experience supporting regulatory submissions (e.g., FDA 510(k), PMA, IND, NDA).
• Familiarity with design control processes and ISO 13485 or similar quality systems.
• Degree in Biostatistics, Statistics, or a related field.

#LI-Onsite

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.

For more information, visit www.danaher.com.