Senior Programmer, EDC Systems

CSL Plasma Inc.; King of Prussia (PA); On-site; USD 143,000 - 169,000; Full time

Job summary

CSL Behring is seeking a Senior EDC Programmer to lead governance, validation, and development of clinical data management systems across in-house, hybrid, and vendor studies. The role emphasizes SDTM/CDASH submission readiness, data quality, and scalable data platforms.

Reporting to the Director, Statistical Programming Lead, you will collaborate with cross-functional teams to ensure regulatory alignment and timely delivery of high-quality data deliverables in a fast-paced environment.

Qualifications

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

Responsibilities

• Drive design, development, and maintenance of clinical study databases (CRF design; database build; edit check programming; report development; system interface configuration)
• Collaborate with clinical study teams, Standards (CDASH/SDTM, CSL), and cross-functional stakeholders to define, implement, and enhance data quality methods, acceptance criteria, and validation rules
• Oversee data quality control frameworks, including validation check libraries and acceptance criteria for vendor and internal data
• Govern and maintain a standardized library of reports and listings to support study teams across in-house, hybrid, and vendor studies
• Oversee setup, automation, and monitoring of recurring data quality and operational reports across different models
• Partner with Data Management, Statistics, and vendors to review and validate clinical data deliverables for regulatory readiness
• Lead reporting solutions that provide insights into data quality, study progress, and key metrics
• Ensure data structures, storage, and integration approaches support pooled analyses and traceability
• Support integration and governance of external data sources, ensuring data consistency and collaboration with internal teams and vendors
• Contribute to innovation and future-state initiatives for scalable data platforms and AI-enabled data processing

Skills

CDISC standards

eCRF design

Medidata Rave

C#

Python

SAS

Veeva Vault

Education

BSc in Computer Science, Mathematics, Statistics or related field

Medidata Rave Study Builder Certification is preferred

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.) 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 relevant experience
• 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.

Benefits:

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

You Belong at CSL

Inclusion and Belonging

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates

#LI-HYBRID