Director – Clinical Programming

• Sets the direction for Clinical Programming within the RWS&A RWD Office and helps shape the function's operating model, priorities, standards, capabilities, and longer-term development.

• Acts as the senior Clinical Programming subject matter expert and primary point of escalation for complex, novel or high-impact programming questions.

• Provides end-to-end oversight and orchestration of programming activities delivered by external partners, including planning, technical direction, quality expectations, issue resolution, and accountability for timely delivery.

• Leads and, where appropriate, performs in-house programming activities in support of the Statistics group, including delivery of analysis datasets, tables, listings, figures, validation, and other fit-for-purpose deliverables.

• Leads the Clinical Programming contribution to artificial intelligence and automation initiatives, including serving as SME on AI workstreams, identifying and accelerating high-value use cases, and driving implementation within the function.

• Uses and advocates for approved AI-enabled tools, where appropriate, to improve efficiency and quality while ensuring validation, traceability, human oversight, and compliance with applicable policies.

• Makes autonomous, risk-based decisions on programming strategy, resourcing, standards, tools and delivery approaches, escalating only matters with broader functional or business impact.

• Ensures programming deliverables are accurate, traceable, reproducible, audit-ready and compliant with applicable internal standards, industry standards and regulatory requirements.

• Establishes fit-for-purpose governance and quality controls across internal and outsourced programming, and drives timely resolution of delivery, quality, compliance and capacity risks.

• Builds strong partnerships with Statistics, Data Management, Data Science, Epidemiology, Evidence Delivery and other stakeholders to translate study and analysis needs into executable programming plans.

• Develops and implements programming standards, reusable solutions, templates, automation, and best practices that improve consistency, quality, scalability and cycle times across the portfolio.

• Provides strategic input to portfolio planning, capacity management, sourcing, and vendor strategy for programming activities.

• Influences senior internal and external stakeholders through clear technical recommendations, evidence-based decisions and pragmatic solutions.

• Provides technical leadership, coaching and mentorship to junior programmers and contributes to capability building, knowledge sharing, recruitment and onboarding.

• Maintains up-to-date expertise in clinical programming, real-world evidence, emerging technologies, AI, relevant industry standards and regulatory expectations, and translates developments into practical improvements for the department.

Education, Qualifications, Skills and Experience

Essential

• Degree in Mathematics, Statistics, Computer Science, Engineering, Life Sciences or another relevant quantitative discipline, or equivalent experience.

• Extensive industry experience in clinical or statistical programming, including demonstrated leadership of complex programming deliverables and projects.

• Advanced SAS programming skills with a high degree of proficiency in SAS macros.

• Experience creating or validating SDTM and ADaM datasets and tables, listings and figures.

• Deep knowledge of clinical and real-world evidence generation, the clinical development process, analysis data flows and programming deliverables.

• Strong knowledge of applicable programming, data and reporting standards, with the ability to define and implement fit-for-purpose standards.

• Experience leading AI, automation or digital workstreams and translating emerging technology into controlled, practical business use.

• Hands-on experience using AI-enabled tools to support programming, validation, documentation or workflow efficiency.

• Demonstrated experience overseeing programming delivered by CROs or other external partners and holding partners accountable for quality, timelines and issue resolution.

• Demonstrated ability to lead and deliver in-house programming activities, including planning, technical review, validation and documentation.

• Proven ability to operate with autonomy, make sound risk-based decisions and provide direction in complex or novel situations.

• Experience leading cross-functional initiatives and influencing senior stakeholders without relying on direct authority.

• Strong understanding of quality, traceability, reproducibility, audit readiness and regulatory expectations relevant to programming.

• Demonstrated ability to develop people through coaching, technical guidance and mentorship.

• Strong communication, collaboration, planning, prioritization and vendor-management skills.

• Experience programming for observational studies, pragmatic trials, or other real-world evidence studies.

• Strong working knowledge of at least one additional relevant language or technology, such as R, Python, SQL or XML.

• Experience developing reusable programming frameworks, macros, packages, templates or standards.

• Statistical modelling experience.

• Relevant professional certification, such as SAS certification.

• People-management or matrix-leadership experience.