Lead Statistician

Lead Statistician – Smith+ Nephew, Andover, MA

Life Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living.

We’re looking for an innovative Lead Statistician to drive statistical strategy and delivery for Smith+ Nephew’s Sports Medicine & ENT portfolio. This role leads complex studies and provides program-level oversight for all statistical activities–study design, analysis, interpretation—ensuring quality and scientific rigor. You’ll mentor statisticians, manage technical reviews, and coordinate resources in a matrixed environment. Champion innovative methods and align with global clinical and regulatory standards.

• Serve as the technical lead and statistical authority for the SPM/ENT 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 conduct technical review of statisticians within the SPM/ENT statistics pod, promoting professional growth and excellence.
• Provide expert 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.
• 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 SPM/ENT 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.

• Minimum of a Master’s degree (Ph.D. preferred) in Statistics, Biostatistics, Applied Mathematics, or a related quantitative research discipline.
• At least 6 years applied experience as a clinical statistician in an academic or industry setting.
• Proven experience in leading statistical activities or teams in a matrixed environment.
• Demonstrated expertise in study design, advanced modeling, and statistical programming (SAS and R).
• Strong understanding of regulatory and clinical research standards (e.g., FDA ISO 14155, ISO).
• Excellent communication skills, with the ability to clearly and confidently explain statistical reasoning to non‑statistical audiences.
• Proven ability to inspire, mentor, and elevate the technical capabilities of peers and junior staff.
• Experience with simulation, causal inference, and clinical registry data analysis preferred.
• Preferred:
  Familiarity with CDISC standards and data integration workflows across…