Director, Clinical Programming

• Sets the direction for Clinical Programming within the RWS&A RWD Office and helps shape the functions 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.