Managing Staff, Clinical Data Science

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Primary Function of Position The Managing Staff, Clinical Data Science role leads a small, highly technical team responsible for extracting insight from diverse healthcare data to inform product, clinical, and business decision-making. This role combines people, technical, and strategic leadership, in an area with substantial ambiguity and evolving priorities. The individual in this role will oversee a small team of scientists and/or technical contributors working across clinical study data, device and system log files, electronic medical records, HEOR databases, and other structured and unstructured datasets. He/she will define the team's technical direction, ensure strong analytical and engineering practices, and build the infrastructure, methods, and operating model needed to deliver high-quality, decision-relevant analyses at scale. This leader will work closely with stakeholders across Medical Affairs, Clinical Affairs, Market Access, HEOR, product management, engineers, R&D, regulatory, commercial and other cross-functional teams to shape strategy, generate publications, and contribute to product features. Success in this role requires strong technical judgment, excellent communication and stakeholder management skills, and the ability to create clarity and momentum in a high-ambiguity environment. The core function includes translating complex biological, procedural, and device-generated data into rigorous clinical & health-economic evidence. This includes simple trial data management all the way to advanced predictive modeling and evidence generation. Essential Job Duties Team Leadership and People Management Lead, coach, and develop a technical team of individual contributors. Set clear goals, priorities, and expectations for the team, while supporting individual growth and career development. Mentor team members on technical topics, including analytical methods, data interpretation, and reproducible workflows. Build a strong team culture grounded in scientific rigor, collaboration, accountability, and continuous improvement. Allocate resources effectively across competing priorities and evolving business needs Evidence Generation Trial Design Support: Collaborating with Clinical Affairs and Principal Investigators to define data collection strategies, endpoints, and statistical analysis plans (SAPs) for pre-market and post-market trials. HEOR Integration: Generating the specific data cuts and statistical models required by HEOR teams, crucial for building cost-effectiveness models and securing positive HTA for market access in various regions. Regulatory Submissions: Structuring and validating clinical datasets to meet strict FDA and EU MDR compliance standards, in collaboration with Clinical Affairs. Advanced Analytics on Device-Generated Data Analyze and extract the clinical meaning from telemetric and procedural data. Build ML models to analyze procedural, kinematic, imaging data to identify factors that correlate with successful patient outcomes. Identifying novel digital (and traditional) biomarkers that can predict procedural success or complication risks. Real-World Evidence (RWE) & Post-Market Surveillance Longitudinal data tracking and analysis from registries, EMR, and device telemetry to monitor long-term safety and performance. Develop automated statistical methods to detect early signals of adverse events. Inform Product Roadmap Translate clinical data insights into actionable feedback for the product development teams, directly influencing the 8 year product roadmap and feature release timelines for next-generation system Technical Leadership Establish and maintain best practices for data management, analytics, code quality, reproducibility, documentation, and validation. Ensure the team uses fit-for-purpose methods and scalable infrastructure to support analyses across diverse data sources. Guide the design and evolution of the team's analytical environment, tools, and workflows to improve efficiency, quality, and reusability. Guide the technical infrastructure. Partner with data engineering to design how clinical data flows from the hospital setting (or trial EDC systems) into secure, compliant internal databases. Provide technical oversight on complex analyses, ensuring outputs are scientifically sound, clearly communicated, and decision-useful. Strategy and Direction Partner with stakeholders to understand near-, mid-, and long-term business priorities. Identify the key decisions, questions, and uncertainties that require analytical support. Guide technical teams in applying rigorous methods to generate insights that inform business decisions. Balance and prioritize competing short- and long-term projects. Anticipate future data, methodology, and organizational needs and shape the team accordingly. Make sound decisions in the absence of perfect information and help others navigate ambiguity with clarity and structure. Required Skills and Experience Significant professional

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Company Intel

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