Senior Programmer, Clinical Data Evaluation

Position Purpose:

The Senior Programmer for Data Validation supports cross-functional teams such as Statistics, Data Management and Standards by overseeing and ensuring the quality of clinical data build and programming activities across in-house, hybrid, and vendor-supported studies. The role focuses on governance, review, and validation of deliverables to ensure alignment with CSL standards, regulatory requirements, and industry best practices. The incumbent applies strong expertise in CDASH and SDTM mapping, eCRF development, and EDC systems (e.g., Medidata Rave, Veeva Vault) to validate datasets, specifications, and vendor artifacts. The role will contribute to shaping future-state data capabilities by supporting initiatives around scalable

data platforms and AI-driven automation, enabling more efficient and intelligent use of clinical data.

Reporting Relationships:

This role reports to:

• Senior Director, Programming

• Director, Programming - Center of Excellence

Work Environment:

*** On site / Hybrid at CSL Behring requires a minimum of 3 days in the designated work location office weekly for this role.  Relocation and mobility assistance is not provided.

Main Responsibilities and Accountabilities:

• Collaborate with clinical study teams, Standards, and cross-functional stakeholders to define, implement, and continuously enhance data quality methods, acceptance criteria, and validation rules for eCRF and external data sources across all study models

• Oversee the implementation and maintenance of data quality control frameworks, including validation check libraries and acceptance criteria for vendor and internally generated data, ensuring alignment with CSL standards and regulatory expectations

• Govern and maintain a standardized library of reports and listings to support study teams, ensuring consistency, reusability, and efficiency across in-house, hybrid, and vendor-supported studies

• Oversee the setup, automation, and monitoring of recurring data quality and operational reports across different models (in-house vs outsourced etc.)a ensuring accuracy, completeness, and timely availability of outputs

• Partner with Data Management, Statistics, and vendors to review and validate clinical data deliverables, ensuring submission readiness in accordance with regulatory standards (e.g., SDTM, ADaM, define.xml)

• Lead the development and oversight of data visualization and reporting solutions that provide insights into data quality, study progress, and key metrics to support informed decision-making

• Ensure appropriate data structures, storage, and integration approaches that enable pooled analyses, traceability, and efficient retrieval of both current and legacy clinical data

• Serve as a subject matter expert in CDASH, SDTM mapping, and EDC systems, providing guidance on data standards, eCRF design, and validation approaches to internal teams and external partners

• Support the integration and governance of external data sources (e.g., IxRS, eDiaries, labs, ECG), ensuring data consistency, quality, and alignment with study requirements, while facilitating collaboration between internal teams and vendors

• Contribute to innovation and future-state initiatives by supporting the development of scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing, validation, and analytics

Job Qualifications and Experience Requirements:

Education

• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

• Other degrees and certifications considered if commensurate with related programming experience

Experience

• 5+ years of relevant experience (clinical data management, clinical programming, or a related function within a pharmaceutical or CRO environment, with exposure to in-house, hybrid, and/or vendor-supported study models)

• Strong understanding of clinical data processes, including data standards, data flows, and integration of eCRF and external data sources, data quality oversight, validation processes, and vendor deliverable review

• Proficiency in SAS and familiarity with Python, R, or C# is a plus to support automation and advanced analytics

• Solid knowledge of CDISC standards, including CDASH, SDTM, and ADaM, with practical experience in data mapping, validation, and submission readiness