Principal Programmer, CDISC SME

Job not on LinkedIn

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

🦅 H1B Visa Sponsor

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👻 Ghost score 23%

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Provide CDISC subject matter expertise across clinical studies, submissions, and standards-related activities • Interpret, implement, and oversee CDISC standards including CDASH, SDTM, ADaM, define.xml, annotated CRFs, Reviewer’s Guides, and related submission documentation • Review datasets, annotated CRFs, define.xml, Reviewer’s Guides, and CDISC-based e-submission packages • Ensure accuracy, consistency, traceability, compliance with client standards, and regulatory alignment • Advise study teams, statisticians, programmers, Data Management, Technology Enabled Science, CROs, and other stakeholders • Design data structures and specifications for SDTM and ADaM datasets, tables, figures, listings, analysis submission content, integrated summaries, and exploratory analyses • Lead or oversee production, validation, and review of programming deliverables produced internally and by CROs • Support CDISC and client standards governance and standardization initiatives • Develop or review standards documentation, processes, guidance, templates, and training materials • Provide mentorship, knowledge sharing, presentations, and training • Identify process gaps and standards inconsistencies and develop global tools, processes, and practices to improve programming efficiency, quality, and capacity

🎯 Requirements

• Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area • 7+ years of statistical programming experience in a CRO/pharmaceutical environment • Extensive hands-on experience applying CDISC standards to clinical trial and regulatory submission deliverables • Demonstrated expertise in SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, controlled terminology, traceability, and regulatory submission expectations • Experience reviewing, specifying, producing, validating, or overseeing CDISC-compliant datasets and submission packages • Strong understanding of protocols, statistical analysis plans, data management plans, CRF builds, external data transfer specifications, dataset specifications, and analysis output requirements • Experience collaborating with statisticians, clinical programming teams, Data Management, Technology Enabled Science, Standards, study teams, and CROs • Outstanding written and verbal communication skills • Strong leadership and organizational skills • Ability to prioritize individual and team workloads • Ability to lead and collaborate across cross-functional, global teams • Experience overseeing vendor deliverables and aligning with internal stakeholders

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities • Opportunity to work with autonomy and ownership • Support from Cytel while embedded with a pharmaceutical client