uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

This role will be the inaugural in-house Statistical Programmer, responsible for establishing and leading the Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS, as well as performing quality reviews of SAS programs and deliverables, both for in-house analyses and outsourced programming tasks. Additionally, this position will serve as a critical link between the biostatistics and clinical data management group to ensure the delivery of high-quality clinical data. The role will also play a key part in multi-functional project teams, providing strategic and technical expertise as a subject matter expert (SME).

Key result areas (major duties, accountabilities and responsibilities)

• Establish and lead the Statistical Programming group within the Biometrics Department.
• Develop and manage the statistical computing environment, including folder structure and access control.
• Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams.
• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements.
• Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
• Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications.
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
• Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming group.

• Master’s Degree in Statistics, Mathematics, Computer Science, or a related scientific/medical field, with 5+ years of SAS statistical programming experience in a clinical trial setting (industry/CRO).
• Proven problem-solving skills and a strong interest in ongoing learning.
• Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures.
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
• Experience with regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• Strong ability to deliver and communicate effectively in a remote or hybrid work environment.
• Adaptability/Flexibility – The ability to the ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands.
• Organizational and results orientation – Skilled at planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure.

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