Smith+Nephew · 8 hours ago
Lead Statistician
Andover, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$136K/yr - $170K/yr
6+ years expSmith+Nephew is a company focused on designing and manufacturing technology that enhances the quality of life. They are seeking an innovative Lead Statistician to drive statistical strategy and delivery for their Sports Medicine & ENT portfolio, leading complex studies and ensuring scientific rigor in statistical activities.
Medical Device
Responsibilities
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
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 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
Qualification
Required
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
Preferred
Experience with simulation, causal inference, and clinical registry data analysis preferred
Familiarity with CDISC standards and data integration workflows across studies and clinical evidence sources
Experience with Bayesian approaches, causal inference frameworks, and propensity-based methods
Proficiency in version control (e.g., Git) and modern data science collaboration tools
Demonstrated ability to drive innovation and modernization in statistical processes or infrastructure
Benefits
Medical, dental, and vision coverage
401k
Tuition reimbursement
Medical leave programs
Parental leave
Generous PTO
Paid company holidays annually
8 hours of Volunteer time
Wellness offerings such as EAP
401k Matching Program
401k Plus Program
Discounted Stock Options
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Fertility and Adoption Assistance Program
Hybrid Work Model (For most professional roles)
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more!
Company
Smith+Nephew
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Katerina Dodbiba
SVP, CFO Orthopaedics, Sports Medicine & ENT
Pierre Palassian
SVP, CFO Global Operations, Quality and Regulatory Affairs
Recent News
2025-10-06
2025-10-03
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