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Responsibilities:

• The Clinical / EDC Programmer works closely with Data Management as well as a multidisciplinary project team across the life cycle of a study to coordinate and support technical aspects of EDC build, including Rave Custom Function development, Business Objects report development and SAS programming tasks related to data cleaning and reporting.
• The Clinical /EDC Programmer attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback.
• A successful candidate will keep those responsible for project management informed of any issues that might impact project target dates, scope, or budget and will escalate potential problems effectively and in a timely manner.
• The Clinical / EDC Programmer balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• He or she interfaces with clients and vendors as needed to support system integrations (e.g., IRT/Rave integrations, TSDV implementation).
• Reviews and specifies requirements for Rave module integrations (e.g., Coder); facilitates cross-functional team discussions around such integrations, sets up and maintains these integrations; leads validation efforts for Rave integrations, incorporating the cross-functional team as needed.
• Reviews and specifies requirements for novel EDC integrations (e.g., Rave, and external IWRS integration, Rave/ePRO integration), facilitates cross-functional team discussions and/or discussions with external vendor team around such integrations, sets up and maintains these integrations, leads validation efforts for integrations, incorporating the external vendor team as needed.
• Participates in UAT/Validation tasks related to EDC build, metrics report programming, and data listings.
• Consults on study design, as needed, from systems integration perspective.
• Serves as technical support for Rave EDC build, including custom function programming.
• Contributes as needed to support Clinical Data Managers with additional study-build activities, including form, edit check, and study structure.
• Leads the Business Objects and/or SAS programming tasks associated with project-specific metrics reporting, working across the project team to ensure final reports meet the needs of all internal and external stakeholders.
• Leads the SAS programming tasks to convert EDC data and metadata into formats/structures needed for other systems.
• Performs oversight of externally created SDTM datasets and accompanying documentation, ensuring compliance with company and Industry standards for SDTM data.

Requirements:

• BS/BA in Life Science, Computer Science, or related discipline.
• 7+ years of clinical data management and/or statistical programming experience in the pharmaceutical/CRO industry.
• 5+ years of Electronic Data Capture programming (EDC) experience including.
• Medidata Rave EDC and Coder.
• Business Objects.
• ODM based integration of external systems via Rave Web Service API.
• 5+ year experience in SAS programming for clinical reporting needs.
• 5+ years' experience programming or oversight of raw to SDTM data creation.
• Strong working knowledge of FDA & ICH/Google Cloud Platform regulations and guidelines.
• Strong knowledge of CDISC (CDASH/SDTM), medical dictionary coding standards, FDA, and ICH guidelines, Google Cloud Platform, 21 CFR Part 11, Clinical Data Management best practices.
• Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment.
• Experience with DIA TMF reference model pertaining to CDM documentation.
• Certified Medidata Rave Architect with C# Custom Function development experience
• Ability to program reports and external edit checks using SAS.
• Ability to oversee and ensure compliance of externally mapped SDTM datasets and accompanying documentation as per NN and Industry standards.