Senior Clinical Programmer
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Cytel
Harrisburg, PA (In Person)
Full-Time
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Job Description
We are seeking an experienced and skilled Clinical Programmer with a strong background within clinical programming. The ideal candidate will have 4-6 years of experience in clinical data programming, with a focus on clinical trial systems and data management solutions especially RAVE and Elluminate. This position requires a solid understanding of clinical trials, data integration, and programming techniques to support the creation, validation, and execution of clinical study data in a fast-paced environment.
Key Responsibilities:
+Programming and Development:
Write and maintain code for clinical trial data processes, including data extraction, transformation, and analysis using the multiple programming environment. +Data Management and Quality:
Ensure accurate and timely delivery of clinical trial data by performing data checks, validation, testing, and reconciliation in line with clinical trial timelines and regulatory requirements. +Collaboration:
Work closely with clinical data managers, statisticians, and other stakeholders to design and implement clinical data flow, ensuring compliance with all regulatory requirements. +Troubleshooting and Issue Resolution:
Identify, investigate, and resolve any issues that arise within the platform or clinical data programming processes. +Documentation:
Maintain comprehensive documentation of programming processes, code, and data management workflows for audit and regulatory purposes. +Continuous Improvement:
Contribute to the improvement of programming practices, tools, and templates to streamline clinical programming workflows and enhance efficiency. +Training and Mentorship:
Provide guidance and mentorship to junior programmers, ensuring adherence to best practices and facilitating knowledge sharing within the team. +Experience:
- 4-6 years of experience in clinical programming. +
Technical Skills:
- + Proficient in clinical data programming languages (e.g., SAS, R, SQL, etc.). + Expertise in clinical programming platforms, including experience with clinical data workflows, data integration, and programming solutions. + Strong knowledge of clinical trial data structures, data standards (e.g., CDISC, SDTM), and regulatory requirements (e.g., FDA, EMEA). +
Problem-Solving:
- Excellent troubleshooting and problem-solving skills with the ability to work under pressure to meet deadlines. +
Communication:
- Strong communication skills with the ability to collaborate effectively with cross-functional teams and communicate technical concepts to non-technical stakeholders. +
Education:
- Bachelor's degree or higher in Computer Science, Life Sciences, Engineering, or related field (or equivalent work experience).
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