As our Lead Postmarket Surveillance Data Scientist, you'll spearhead efforts to collect, analyze, and interpret vast arrays of postmarket data. This isn’t just about identifying trends; it's about using your expertise to drive strategic insights that influence product lifecycle management, patient safety, and regulatory compliance. Your work will directly impact how we monitor product performance, assess risk, and protect patient health at a global scale.
This is an opportunity to be a leader in an emerging field, where your contributions will have both immediate and long-term influence in the healthcare industry.
Key Responsibilities:
Lead Data Analysis: Lead the design and implementation of advanced statistical models to analyze postmarket surveillance data from diverse sources such as clinical trials, real-world evidence, and adverse event reports.
Risk Assessment & Safety Monitoring: Identify potential risks related to medical devices and therapeutic products. Use data to generate actionable insights and predict potential issues before they escalate.
Cross-Functional Collaboration: Work closely with product development teams, regulatory affairs, and clinical teams to integrate surveillance findings into the product lifecycle, driving continuous improvements and ensuring compliance.
Develop Predictive Tools: Innovate by creating predictive analytics tools that proactively alert teams to potential issues, enabling timely intervention and better safety outcomes.
Regulatory Reporting & Compliance: Ensure that all surveillance data adheres to FDA, EMA, and other global regulatory requirements. Prepare and present clear reports that communicate findings to internal and external stakeholders.
Thought Leadership & Strategy: Drive the evolution of our postmarket surveillance strategy by staying up-to-date with industry trends, technological advancements, and regulatory changes. Develop and mentor a high-performing team of data scientists.
What We’re Looking For:
Experience: At least 5 years of experience in postmarket surveillance, risk management, or related fields within the healthcare or medical device industry. Proven leadership experience managing data science teams is highly desirable.
Technical Expertise: Proficiency in advanced data analytics, machine learning, and statistical modeling tools. Familiarity with software such as R, Python, SAS, or SQL.
Industry Knowledge: Strong understanding of medical device lifecycle management, regulatory requirements (FDA, EMA), and postmarket surveillance practices.
Problem-Solving Skills: Ability to turn complex datasets into actionable insights that drive improvements in safety, quality, and compliance.
Communication Skills: Strong presentation skills with the ability to distill complex data into clear, concise, and actionable reports for both technical and non-technical audiences.
Education: A Master’s or Ph.D. in Data Science, Statistics, Epidemiology, or a related field is preferred.
