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.