Typical Accountabilities
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.
Desirable
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.
Key Relationships to reach solutions
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, quality and standards workstreams
Clinical Programming colleagues and broader programming communities
External (to AZ)
CRO and vendor programming leads, project managers and technical teams
Technology and service providers supporting programming, automation or AI initiatives
Other external partners and collaborators, as required.
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.
