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Principal Clinical Programmer (SDTM SME)

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Primary Location: Durham, North Carolina, United States Full time R1284231

Job description

Main Responsibilities and Accountabilities: 
    Ensures that data from multiple source systems is pulled integrated into datasets that support the creation of data visualizations
    Collaborates in the development of strategies for the integration of non eCRF data in the eCRF database (eg, IRT integration) provides technical support to internal team members as well as to external vendors as requested by study teams
    Defines metadata for various data sources in the metadata repository system to allow automated processing of incoming and outgoing data for all data sources used in the reporting and visualization of clinical study and operational data.
    Collaborates in the set-up and maintenance of a suite of data visualizations, eg, Data Management Dashboard, Medical Monitoring Dashboard, and additional visualizations as required by the study teams
    Defines the mapping of data collected in eCRFs or eCOA tools into standardized formats following the CSL Behring’s SDTM+ standard 
    Communicates about the potentials of data visualizations and collects study specific requirements with study teams
    Programs, quality controls and implements data visualizations including the relevant documentation
    Programs, quality controls and implements data visualizations including the relevant documentation
    Collaborates with peers, data management, statistics and external service providers to ensure the quality, accuracy and user friendliness of data visualizations and custom data reports on study data

Qualifications and Experience:
    Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience
    Other degrees and certifications considered if commensurate with related data management experience 
    At least 3 years of experience in either clinical data management, clinical and/ or statistical programming, within the CRO/ pharmaceutical environment
    Understanding of data management, clinical and/ or statistical programming processes and standards including metadata management
    Strong SAS programming skills including SAS macro
    Strong knowledge in CDISC standards (CDASH, SDTM, ADaM)
    Java programming skills welcome
    Medidata Rave knowledge welcome
    Ability to work effectively in a team setting, and to meet set goals by managing own timelines
    Ability to work in cross-functional, multi-cultural and international clinical trial teams
    Good planning and organizational skills
    Networking skills and ability to share knowledge and experience amongst colleagues
    Fluent in English, oral and in writing

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