Scientist III, Biostatistics
When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How Will You Make An Impact?
As a Biostatistician in the Clinical Genetic Testing Solutions Group at Thermo Fisher Scientific, you will be responsible for leading all statistical aspects of diagnostic product development programs. You will provide expert statistical consultation and comprehensive data-analytic support (including computation of experiment size) for the design of prospective as well as retrospective studies and work closely with a cross-functional group including Research Scientists, Software Developers, Project and Product Managers, Regulatory Affairs, and Quality Assurance. You will deliver high quality statistical outputs (protocols, statistical study reports, etc.) in an efficient and timely manner in support of submissions to regulatory authorities or for publication.
Key Accountabilities/Core Job Responsibilities
- Work in the Research and Development Department to establish and lead efforts aimed at assuring proper design and timely execution of development, analytical, and clinical diagnostic studies
- Provide statistical input into analytical and clinical study protocols and reports
- Work with cross-functional teams on special projects requiring statistical analysis
- Bachelor’s in Molecular Biology, Biology, Chemistry, Applied Mathematics, Computational Biology, Biostatistics, Bioinformatics, Computer Science or related discipline; postgraduate degree (Masters, PhD) is highly preferred
- 2+ years of experience in clinical diagnostics
- Understanding of analytical validation and clinical trial design and evaluation
- Prior experience with US-FDA 510(k) product development/submission, 21 CFR Part 11, and CLSI standards
- Strong hands on data analytics, statistical modeling, and design of experiment experience
- Data structures and common methods in data transformation
- Pattern recognition and predictive modeling skills
- Excellent programming skills in R, SAS, JMP and/or Python
- Experience utilizing Matlab, PSS, C++, Java or Minitab a plus
- Ability to adapt to change and take on unexpected challenges a must
- Excellent communication skills both written and verbal
- Ability to present and communicate data analysis results to non-experts