Job Description

Job Responsibilities:

• Responsible to define case report forms (CRFs) specifications in accordance with SDTM guideline and standards and leads the cross functional review and approval process.
• Responsible to define external (non CRF) data specifications in accordance with Biometrics standards
• Responsible to define data flow and to ensure that study databases meet requirements by performing User Acceptance Testing (UAT)
• Responsible to perform, supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
• Responsible to perform data handling activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock.
• Responsible to program SAS or SQL based clinical and operational listings and reports • Responsible to follow Clinical Programming processes and perform programming activities related to clinical, external and operational data receipt and reporting to ensure the data meets requirements and is reported with highest quality to all stakeholders
• Develop positive partnerships with CROs and ensure a high standard of deliverables is maintained • Has a good understanding of SAS macros, programs, reporting tools, infrastructure and has programming skills to develop new features, programs and macros
• Serves as the focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
• Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Data Management Lead.
• Thorough understanding of Clinical data, SDTM IG and Pinnacle 21

Skills:

• Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis.
• Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
• Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.

Education/Experience:

• Bachelor’s or higher degree in science or technology or equivalent combination of education and related work experience
• 5+ years of Sr Programming Lead professional experience.

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