※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
We are leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.
<Essential Duties and Responsibilities>
Work with Regulatory, Laboratory Operations, Medical Affairs, and Marketing teams to provide bioinformatics support as a Subject Matter Expert on Next-Generation Sequencing (NGS) oncology diagnostic assays. Responsible for bioinformatics documentations for the regulatory submission, authoring development reports and laboratory validation reports, and sustain and support efforts for laboratory testing.
- Understand regulatory submission documentations and relay relevant information to the Regulatory team.
- Understand and defend analytical experiments.
- Understand statistical methods and procedures used in clinical assay validations.
- Interface with the oversea bioinformatics team to support Regulatory team and the regulatory agency inquiries.
- Author required development reports using existing data set.
- Analyze and author laboratory NGS assay validation results.
- Sustain and Support production laboratory testing, including Quality Control results, patient results and reports.
- Ph.D. or M.S. in Bioinformatics, Computational Biology or related field. Equivalent industry experience accepted.
- Familiar with NGS data formats and tools
- Ability to develop analyses, models, and reproducible reports with Python or R
- Experience developing or validating tests or devices in a collaborative or regulated environment
- Experience troubleshooting, maintaining, or launching of a medical product is preferred
- Experience analyzing, troubleshooting, and visualizing wet lab experiments
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.