Position Purpose:
The Senior EDC Programmer 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 leading and overseeing set-up and maintenance of Clinical Data Management Systems in addition to providing technical support. This individual 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 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 the Director, Statistical Programming Lead
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:
Drive activities related to the design, development, and maintenance of clinical study databases by applying advanced technical expertise in: CRF design; database build; edit check programming; report development; custom programming; system interface configuration; and the implementation of all relevant systems features to support high-quality, compliant clinical data management.
Collaborate with clinical study teams, Standards (CDASH/SDTM,CSL), 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, define.xml)
Lead the 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
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 relevantexperience
Medidata Rave Study Builder Certification is preferred
Experience
5+ years of relevant experience with clinical database design in EDC systems within a pharmaceutical or CRO environment
Exposure to in-house, hybrid, and/or vendor-supported study models
Familiarity/practical experience with CDISC standards, particularly CDASH, SDTM including data mapping, validation, and activities supporting submission readiness
Proficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks
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
Proven ability to manage priorities, meet timelines, and operate effectively in a fast-paced and evolving environment
Ability to independently perform data migration activities for post-production study changes is preferred
Experience with C# is preferred and familiarity with SAS, Python, or R is a plus
Competencies
Good communication and analytical skills
Good planning and organizational skills
Ability to work successfully in a matrix organizational structure
Networking skills and ability to share knowledge and experience amongst colleagues
Fluent in English, oral and in writing
The expected base salary range for this position at hiring is $143,000 - $169,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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