Senior Statistician - Medical Devices

We are seeking a driven and innovative Lead Statistician to serve as the technical lead for statistical strategy and delivery within the company's Orthopedic Reconstruction & Robotics portfolio, reporting to the Head of Global Data Analytics. This role directly supports high impact/complexity studies and provides program-level and technical leadership across all statistical activities in the business unit. This includes study design, analysis, and interpretation, and ensuring quality, consistency, and scientific rigor across the business unit’s portfolio.

• Serve as the technical lead and statistical authority for the Orthopedic Reconstruction & Robotics portfolio, providing strategic input across all stages of clinical evidence generation
• Champion innovative statistical methodologies and study designs, fostering consistency, quality, and scientific rigor across programs
• Partner with cross-functional leadership to ensure statistical approaches are aligned with regulatory expectations, scientific best practices, and business priorities
• Mentor, coach, and technical review the work of statisticians within the Orthopedic Reconstruction & Robotics statistics pod, promoting professional growth and excellence in execution
• Provide expert statistical guidance in the design of clinical studies and registries, including sample-size estimation, randomization, adaptive and hybrid designs, and simulation-based planning
• Collaborate with clinical operations, data, medical affairs, and clinical strategy teams to define study type, endpoints, estimands, and analysis frameworks that are robust, transparent, and fit for regulatory submission as applicable
• Oversee the planning and conduct of complex statistical analyses, ensuring appropriate methods are applied (e.g., survival analysis, mixed-effects models, Bayesian frameworks, causal inference methods, propensity scores)
• Ensure statistical deliverables meet quality and reproducibility standards, performing or delegating technical review as required
• Utilize and guide others in the effective use of SAS, R, and emerging analytical tools, fostering continuous learning and modernization of analytical workflows
• Provide technical oversight of data cleaning, derivation, and integration activities in collaboration with Data Management, Programming, and Data Science teams
• Establish and enforce quality control and validation practices for all statistical deliverables across the Orthopedic Reconstruction & Robotics portfolio
• Translate complex statistical findings into clear, actionable insights for clinical, regulatory, and executive stakeholders
• Lead or contribute to the statistical content of Clinical Study Reports (CSRs), regulatory submissions, publications, and cross-portfolio summaries
• Maintain awareness of emerging statistical methodologies, regulatory guidance, and data standards relevant to medical device research
• Act as a thought partner and catalyst for innovation, promoting adoption of modern statistical approaches, simulation, and automation in the analysis lifecycle
• Support the development and harmonization of statistical SOPs, best practices, and governance frameworks across Global Clinical and Medical Affairs

• Master’s and 5 years applied experience, or Ph.D. and 2 years applied experience as a clinical statistician in an academic or industry setting