Senior Programmer, EDC Systems

CSL Plasma; Waltham (MA); Hybrid; USD 143,000 - 169,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

CSL Behring seeks a Senior EDC Programmer in Waltham, MA to govern the setup and validation of clinical data management systems across in-house, hybrid, and vendor-supported studies.

You will lead data quality, validation rules, and reporting, collaborating with Statistics, Data Management, and Standards to ensure regulatory readiness and scalable data capabilities.

Qualifications

• 5+ years of experience designing clinical databases in EDC environments.
• Experience across in-house, hybrid, and/or vendor-supported study models.
• Familiarity with CDISC standards (CDASH/SDTM) and submission readiness.
• Proficiency with EDC systems and programming frameworks.
• Strong data quality oversight and validation processes.

Responsibilities

• Drive design, development, and maintenance of clinical study databases using advanced technical expertise.
• Collaborate with study teams and cross-functional stakeholders to define data quality methods and validation rules.
• Oversee data quality control frameworks, validation libraries, and acceptance criteria for vendor and internal data.
• Govern a library of reports and listings to support study teams across models.
• Oversee setup, automation, and monitoring of recurring data quality and operational reports.
• Partner with Data Management, Statistics, and vendors to ensure submission readiness (SDTM/define.xml).
• Lead reporting solutions to provide insights into data quality and study progress.
• Support integration of external data sources and scalable data platforms.

Skills

EDC programming

CDISC standards

Data management systems

C# (preferred)

SAS/Python/R

English communication

Education

BSc in Computer Science/Math/Stats or related

Tools

Medidata Rave

Veeva Vault

Job description

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.) 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 relevant experience

Job Qualifications and Experience Requirements: 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.

Job Qualifications and Experience Requirements: 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.

Compensation

• The expected base salary range for this position at hiring is $143,000 - $169,000. This salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed 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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