Lead Statistician

Smith & Nephew•Andover, MA

38d•Hybrid

About The Position

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, acting as the statistical authority and thought partner. Champion innovative methods and align with global clinical and regulatory standards. Ideal candidates are lifelong learners with strong foundations in mathematics, biostatistics, and study design, and a passion for innovation. If this sounds like you, apply today!

Requirements

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.

Nice To Haves

Experience with simulation, causal inference, and clinical registry data analysis preferred.
Preferred: Familiarity with CDISC standards and data integration workflows across studies and clinical evidence sources.
Preferred: Experience with Bayesian approaches, causal inference frameworks, and propensity-based methods.
Preferred: Proficiency in version control (e.g., Git) and modern data science collaboration tools.
Preferred: Demonstrated ability to drive innovation and modernization in statistical processes or infrastructure.

Responsibilities

Statistical Leadership and Strategy: 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 technical review the work of statisticians within the SPM/ENT statistics pod, promoting professional growth and excellence in execution.
Study Design and Planning: 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.
Statistical Analysis: 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.
Data Management and Quality: 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.
Results Interpretation and Reporting: 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.
Thought Leadership and Continuous Improvement: 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.