Director, Clinical Programming

Location: Barcelona - Spain (3 days working from the office and 2 days working from home).

BioPharmaceuticals Medical (BPM) strives for the best patient outcomes by providing healthcare decision-makersaround the world with the evidence and confidence they need on AstraZeneca therapies, as well as supporting our internal stakeholders with medical insights and expertise. BPM provides medical leadership with market participation and connectivity while also impactinglife cycle planning and execution of all our products. BPM aims to lead AstraZeneca in advancing its scientific leadership, being a great placeto work, and keeping patients at the core of everything we do.

The Director, Clinical Programming is a senior subject matter expert and functional leader within RWS&A RWD Office Clinical Programming. The role is accountable for shaping and delivering high-quality, efficient, and fit-for-purpose clinical programming that supports the Statistics group and broader evidence generation portfolio. The incumbent provides strategic and technical leadership across both outsourced and in-house programming activities, independently makes decisions on programming approaches, standards, quality, and risk, and orchestrates delivery across internal teams and vendor partners. The Director also leads the development and adoption of AI and automation initiatives within the function, serves as the Clinical Programming SME on relevant AI workstreams, and provides guidance and mentorship to other programmers.

TypicalAccountabilities

• 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, novelor 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 timelydelivery.

• Leads and, where appropriate, performsin-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, identifyingand accelerating high-value use cases, and driving implementation within the function.

• Usesand 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, toolsand delivery approaches, escalating only matters with broader functional or business impact.

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

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

• Builds strong partnerships with Statistics, Data Management, Data Science, Epidemiology, Evidence Deliveryand 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, scalabilityand 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 decisionsand pragmatic solutions.

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

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

Education,Qualifications,SkillsandExperience

Essential

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

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

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

• Experience creating or validating SDTM and ADaMdatasets and tables, listingsand figures.

• Deep knowledge of clinical and real-world evidence generation, the clinical development process, analysisdata flowsand programming deliverables.

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

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

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

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

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

• Proven ability to operatewith autonomy, make sound risk-based decisionsand 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 readinessand regulatory expectations relevant to programming.

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

• Strong communication, collaboration, planning, prioritizationand vendor-management skills.

Desirable

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

• Strong working knowledge of at least one additionalrelevant language or technology, such as R, Python, SQLor XML.

• Experience developing reusable programming frameworks, macros, packages, templatesor standards.

• Statistical modelling experience.

• Relevant professional certification, such as SAS certification.

• People-management or matrix-leadership experience.

KeyRelationshipstoreachsolutions

Internal (to AZ or team)

• Leadership and all levels across BPM Evidence/RWS&A

• RWS&A RWD Office and BPM Evidence Statistics

• Data Management, Data Science, Epidemiology and Evidence Delivery partners

• Study and project functional leads

• AI, automation, technology, qualityand standards workstreams

• Clinical Programming colleagues and broader programming communities

External(toAZ)

• CRO and vendor programming leads, project managersand technical teams

• Technology and service providers supporting programming, automationor AI initiatives

• Other external partners and collaborators, as required.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.