Clinical Data Programmer

New Haven, Connecticut, United States | Full-time


Job Summary:

The Clinical Data Programmer provides advanced data management support to internal study and scientific teams. This is a technical role involving both advanced software capabilities and a strong understanding of good clinical data management practices. This position supports deployed software applications in a regulated environment and their use within Invicro Data Management and across other research areas of the organization.

Major Responsibilities:

  • Develop data collection forms to maximize efficiencies in data acquisition across multiple imaging modalities and therapeutic areas.
  • Provide internal Core Lab data analytics support to study teams and upper management
  • Utilize analytic tools to program/generate summarization of study data to support study teams and overall scientific interests
  • Define and implement new processes and workflows through cross-department collaboration
  • Collect and design new software application requirements for development of software applications/modules. Communicate design requirements to software development personnel.
  • Design and develop custom calculations, error checks, and automated data validation routines.
  • Identify requirements and create customized reports from Core Lab systems for internal and external customers.
  • Build data conversion paths and develop efficient and appropriate sponsor deliverable file formats, including CDISC SDTM and ODM compliance requirements
  • Assist with the development of data integrations for continuity across internal data platforms (sites, sponsors, Invicro locations)
  • Participate in software user requirement definitions and updates, representing comprehensive data management from data acquisition through the data reporting study lifecycle.
  • Move internally developed technology forward and manage transition of historic data into new platforms
  • Provide coaching, support and mentoring to less experienced team members in data management practices and related technical issues
  • Support DM personnel in the development of technical documentation
  • Advise on the development of database quality standards including the oversight of standard eCRF library and version control processes.



  • Bachelor’s Degree in mathematics, computer science or equivalent demonstrated technical and analytical experience.
  • Strong documentation and reporting capabilities.
  • Detail oriented self-learner capable of training those in use of data analytics and data management practices.
  • Possess strong written and verbal skills for effectively communicating with departmental staff and research centers.
  • Experience implementing CDISC standards
  • Strong understanding of GxP
  • Expert level understanding of 21 CFR Part 11
  • Median level SAS programing experience
  • Experience with EDC (e.g. Open Clinica, RAVE, Inform, TrialMaster, etc.)
  • Master level SQL proficiency
  • Median level Javascript proficiency
  • 5+ years’ experience in data management


  • Advanced development of data management tools, analytic software, internal software.
  • Experience working with sponsors on complex data management and analytical outputs.
  • Working knowledge of FDA Guidance Documents / EU Directives.
  • Experience working with research data and clinical development support.
  • Comprehensive understanding of the clinical drug and/or device development process
  • Expert level SAS programming experience
  • Experience with Alfresco software
  • Additional languages Visual Basic, C#, Pearl, Python a plus
  • Expert level understanding of XML and JSON code
  • Previous experience in the entire data management life cycle with at least 1 large phase III study.


Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.