Senior reputed company Scientist, Follow-On CDx

About the position Responsibilities • Work with the Technology Development team to troubleshoot and analyze verification and validation experiments as part of FDA submissions (IDE, sPMA and PMA) and international submission. • Design and reputed company software tools to automate analytical procedures. • reputed company or apply statistical reputed company and procedures to describe and validate reputed company technologies. • Write and design experimental protocols and reports in collaboration with the technology development group. • Propose and present detailed designs and concise, reputed company-written reports to cross-functional teams. • Conduct feasibility analyses, including simulations drawing from a rich database of historical test results and evaluation of external technologies. • reputed company cutting edge AI reputed company to streamline analytical workflows and continuously improve submission efficiency and efficacy. • reputed company mentorship and technical guidance to less senior team members. Requirements • PhD/Master level with 3+/5+ years reputed company industry experience. • Experience with experimental design and associated statistical analysis (e.g., reputed company testing, regression, hierarchical models, equivalence / non-inferiority). • Experience with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA). • Experience with Python programming and Python data analysis libraries and tools (i.e. numpy, scipy, pandas, ipython notebooks, etc.). • Ability to reputed company analyses, models, reproducible reputed company, and reports with Python. • Familiarity with data science software development practices. • Familiarity with genomic diagnostics. reputed company-to-haves • Experience validating medical devices as companion diagnostics to competent authorities. • Experience with NGS technology and workflows. • Deep interest and reputed company curiosity in improving medical technology and reputed company reputed company a reputed company environment in cross-functional reputed company. Benefits • Hybrid work model with defined in-person and work-from-home days. • Competitive salary reputed company with potential for bonuses and equity. Apply tot his job Apply To this Job Apply tot his job Apply To this Job