Lead Statistician

Posted 4 Days Ago
Be an Early Applicant
Andover, MA
In-Office
136K-170K Annually
Senior level
Healthtech • Biotech
The Role
The Lead Statistician will oversee statistical strategy, design clinical studies, mentor team members, and ensure regulatory compliance in statistical delivery.
Summary Generated by Built In

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!

What will you be doing?

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.

What will you need to be successful?

  • 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 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.

The anticipated base compensation range for this position is $135,850.00 - $170,000.00 USD annually (or hourly) The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Travel Requirements: Up to 10% (domestic).

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

  • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

  • Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  

  • Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  

  • Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program 

  • Flexibility: Hybrid Work Model (For most professional roles)  

  • Training: Hands-On, Team-Customized, Mentorship  

  • Extra Perks: Discounts on fitness clubs, travel and more!  

#LI-HYBRID

#LI-SB2

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Top Skills

Bayesian Frameworks
R
SAS
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The Company
Andover, MA
15,318 Employees

What We Do

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.

From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place.

Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart.

Through a spirit of ownership and can-do attitude, we work together to win..

We’re a company of people who care about each other, about our customers and their patients, and about our communities.

Together, we fulfill our shared purpose of Life Unlimited.

Please note: not all products referred to may be approved for use or available in all markets.

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