Overview
Join to apply for the Biostatistician - R&D role at Leica Biosystems.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Leica Biosystems, part of Danaher, is focused on advancing cancer diagnostics and improving lives. This on-site role is located in Newcastle upon Tyne.
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 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 is a plus.
Travel, Motor Vehicle Record & Physical/Environment Requirements
Travel expectations for this role are Low. Applicable requirements will be communicated if relevant.
Qualifications & Preferences
* 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.
* Experience with regulatory submissions and cross-functional collaboration is desirable.
Join our winning team today. For more information, visit www.danaher.com.
Location: Newcastle Upon Tyne, England, United Kingdom
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