An oncology focused company, utilising advanced testing and analytics to further improve treatments for all stages of cancer.
The company`s oncology platform is designed to leverage their capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.
Work with all areas of the business 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,
Statistical methods and procedures used in clinical assay validations.
Interface with the US bioinformatics team to support Regulatory team and the regulatory agency inquiries.
Analyse 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.
Familiarity 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
Ability to troubleshoot, maintain, or launch a medical product (preferred)
Communications ability in Japanese as well as Business level English