Director, Clinical Data Analytics

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Director, Clinical Data Analytics is the global functional leader responsible for the strategy, scientific rigor, technology architecture, operational execution, and continuous evolution of Smith+Nephew's Clinical Statistics, Clinical Data Management, Statistical Programming, Clinical Programming, Data Science, and Artificial Intelligence capabilities supporting end-to-end evidence generation. This role serves as the enterprise authority for clinical data, statistical methodology, advanced analytics, and AI-enabled evidence generation. The Director is accountable for ensuring clinical data assets, analytical methodologies, and data-driven capabilities support high-quality, regulator-ready evidence while accelerating innovation, operational excellence, and business impact across the product lifecycle. The position has full responsibility for the performance, strategy, quality, budget, talent, and operational delivery of the Clinical Data Analytics function, including Statistics, Clinical Data Management, Statistical Programming, Clinical Programming, Data Science, and AI. The Director serves as a key member of the GCRO Leadership Team and partners closely with Clinical Research, Medical Affairs, Regulatory Affairs, Quality, Digital, and R&D leadership.

What will you be doing?

1. Strategy & Transformation (15%)
- Define and execute the global Clinical Data Analytics strategy and multi-year capability roadmap.
- Translate GCRO and enterprise priorities into functional priorities, investments, and transformation initiatives.
- Identify and advance emerging capabilities and technologies that improve speed, quality, efficiency, and value of evidence generation.
- Serve as the senior functional advisor for statistics, clinical data, and AI.
- Drive transformation through standardization, automation, data integration, and responsible adoption of AI.

2. Functional Leadership (40%)
- Biostatistics: Provide scientific and technical leadership for statistical activities supporting clinical investigations, registries, post-market evidence generation, health economic analyses, and real-world evidence programs. Ensure statistical rigor in study design, protocol development, sample-size determination, statistical analysis plans, and interpretation of study outcomes. Guide the application of innovative statistical methodologies and analytical approaches. Ensure timely delivery of statistical analyses meeting regulatory, scientific, and publication standards. Oversee statistical support for regulatory submissions, clinical study reports, publications, presentations, and external communications.
- Clinical Data Management & Governance: Lead global clinical data management strategy, standards, and operations. Oversee the clinical data lifecycle including data acquisition, eCRF and database design, validation, reconciliation, coding, quality review, and database lock. Establish and maintain data governance frameworks, standards, lineage, and controls. Drive adoption of data standards and best practices. Apply risk-based, analytics-enabled approaches to data review and quality management.
- AI, Data Science & Advanced Analytics: Lead development and deployment of AI, machine learning, predictive analytics, and advanced data science capabilities. Champion responsible, ethical, transparent, and compliant use of AI. Provide functional oversight for synthetic data, virtual twins, simulation modeling, predictive analytics, and other advanced evidence-generation methodologies. Evaluate emerging technologies and industry practices.
- Statistical & Clinical Programming: Lead statistical programming and clinical programming capabilities. Ensure efficient development of analysis-ready datasets, tables, figures, listings, visualizations, data transformations, and reporting outputs. Provide oversight for clinical data architecture, the Clinical Data Lake, data pipelines, system integrations, standardized data models, and analytics infrastructure.

3. People Leadership & Talent Development (20%)
- Lead and develop a multidisciplinary global organization of people managers, technical leaders, and individual contributors.
- Establish the organizational structure, workforce and succession plans, and capability roadmap.
- Recruit, retain, coach, and develop high-performing talent and future leaders.
- Own performance management, development planning, career development, and employee engagement.
- Foster an inclusive culture of scientific excellence, innovation, accountability, collaboration, quality, and continuous learning.

4. Regulatory, Quality & Compliance Oversight (10%)
- Ensure clinical data analytics activities comply with applicable regulations, company procedures, data privacy requirements, and quality standards.
- Represent the function during audits, inspections, and regulatory interactions.
- Support regulatory submissions and responses involving statistical methodology, data management practices, programming outputs, data architecture, and analytical approaches.
- Maintain inspection readiness and proactively identify and mitigate operational, quality, data integrity, and compliance risks.

5. Cross-Functional Partnership & External Engagement (10%)
- Partner with Clinical Research, Medical Affairs, Regulatory Affairs, Quality, R&D, Digital, Health Economics, IT, and business-unit leaders.
- Influence clinical development and evidence-generation strategies through scientific expertise and data-driven insights.
- Build effective relationships with CROs, technology providers, external experts, academic collaborators, and industry organizations.

6. Financial & Operational Management (5%)
- Develop and manage the functional budget, resource plan, vendor strategy, and technology investments.
- Monitor performance indicators and functional metrics.
- Drive continuous improvement and operating-model efficiencies.

Key Interfaces
- Global Clinical Research Operations leadership
- Clinical / Medical Affairs / Regulatory Affairs
- Statistics, Data Science, and AI teams
- IT / Digital / Enterprise Data organizations
- External partners, CROs, AI vendors, and regulators

What will you need to be successful?
- Minimum of 10 years of relevant experience across biostatistics, clinical data management, programming, data science, AI/ML, or data platforms within the medical device, pharmaceutical, biotechnology, or another regulated healthcare industry.
- Demonstrated experience leading multidisciplinary, global teams across biostatistics, clinical data management, programming, data science, AI, or related disciplines, including direct people-management responsibility.
- Demonstrated experience overseeing clinical data architecture, data platforms, governance, and technology-enabled transformation; experience with Databricks or comparable platforms is preferred.
- Strong track record supporting regulatory submissions and clinical evidence generation in a regulated environment.
- Enterprise mindset — integrates data, AI, and operations into a unified capability
- Technical depth + breadth — credible across biostatistics, clinical data management, programming, data science, AI, and analytics
- Regulatory credibility — understands how data and AI decisions impact submissions
- Execution rigor — delivers scalable, high-quality platforms and outputs
- Transformational leadership — embeds AI into workflows, not as isolated innovation
- Pragmatic innovation — advances capabilities while maintaining compliance and reliability

Education: PhD preferred, or Master's degree, in Biostatistics, Statistics, Data Science, Computer Science, or a related quantitative discipline.

You Unlimited.

• Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our 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!  

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.