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For Companies At a Glance
- Tasks: Lead statistical analysis for innovative cancer diagnostics and collaborate with R&D teams.
- Company: Leica Biosystems, a leader in life sciences and biotechnology.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Why this job: Join a mission-driven team focused on advancing cancer diagnostics and improving lives.
- Qualifications: Degree in Biostatistics or related field; experience in R&D and regulatory submissions.
- Other info: On-site role in Newcastle upon Tyne with low travel expectations.
The predicted salary is between 36000 - 60000 £ per year.
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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Biostatistician - R&D employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Biostatistician - R&D
✨Tip Number 1
Network like a pro! Reach out to professionals in the biostatistics field, especially those at Leica Biosystems. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methods and regulatory submission knowledge. We recommend practising common interview questions related to biostatistics and R&D to show you're ready to hit the ground running.
✨Tip Number 3
Showcase your skills with real examples! When discussing your experience, highlight specific projects where you applied biostatistics in R&D. This will help potential employers see how you can contribute to their team.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team at Leica Biosystems.
We think you need these skills to ace Biostatistician - R&D
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Biostatistician role. Highlight your experience in R&D and any relevant projects that showcase your statistical skills. We want to see how you can contribute to advancing cancer diagnostics!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about life sciences and how your background aligns with our mission at Leica Biosystems. Let us know what makes you the perfect fit for the team.
Showcase Your Technical Skills: Don’t forget to mention your proficiency in SAS and any other statistical software you’re familiar with. We love seeing candidates who can translate complex data into actionable insights, so give us examples of how you've done this in the past!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to the right people. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Leica Biosystems
✨Know Your Stats
Brush up on your biostatistics knowledge, especially the methods relevant to IVD devices. Be ready to discuss how you've applied these in past roles, particularly in R&D or regulated environments.
✨Understand the Role
Familiarise yourself with the specifics of the Biostatistician role at Leica Biosystems. Understand their focus on cancer diagnostics and be prepared to explain how your skills can contribute to their mission.
✨Prepare for Regulatory Questions
Since regulatory submissions are a key part of this role, review your experience with FDA submissions and design control processes. Be ready to share examples of how you've navigated these in previous positions.
✨Communicate Clearly
Practice translating complex statistical concepts into simple terms. You’ll need to convey insights to both technical and non-technical stakeholders, so demonstrate your ability to communicate effectively during the interview.
