Senior CDISC SME & Lead Programmer

Cytel; Little Rock (AR); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter leadership across CDISC standards in clinical studies and regulatory submissions. You will work embedded within a global pharmaceutical client, ensuring SDTM, ADaM, CDASH, and define.xml deliverables meet regulatory expectations.

You will mentor teams, review datasets, collaborate with statisticians and CROs, and drive data standardization, quality, and submission readiness across programs with autonomy and ownership.

Qualifications

• Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area.
• 7+ years of statistical programming experience in CRO/pharmaceutical environment.
• Extensive hands-on experience applying CDISC standards to clinical trial and regulatory submission deliverables.
• Proven experience reviewing, specifying, producing, validating, or overseeing CDISC-compliant datasets and submission packages.
• Strong understanding of clinical trial documentation and downstream programming requirements.
• Experience collaborating with statisticians, programmers, Data Management, CROs to ensure submission readiness.
• Outstanding communication skills and strong leadership skills.
• Ability to lead across cross-functional, global teams and oversee vendor deliverables.

Responsibilities

• Provides CDISC subject matter expertise across clinical studies, submissions, and standards-related activities, ensuring appropriate interpretation, implementation, and oversight of CDISC standards, including CDASH, SDTM, ADaM, define.xml, annotated CRFs, Reviewer’s Guides, and related submission documentation.
• Performs SME review of selected datasets, annotated CRFs, define.xml, Reviewer’s Guides, and CDISC-based e-submission packages to ensure accuracy, consistency, traceability, compliance with client standards, and alignment with regulatory expectations.
• Serves as a CDISC consultant to study teams, statisticians, programmers, Data Management, Technology Enabled Science, CROs, and other stakeholders by providing guidance on study setup, data standards, dataset design, standards interpretation, submission readiness, and issue resolution.
• Collaborates with study statisticians and programming colleagues to design data structures and specifications for study and ad hoc deliverables, including SDTM and ADaM datasets, tables, figures, listings, analysis submission content, integrated summaries, and exploratory analyses.
• Leads or contributes to the production, validation, review, and oversight of programming deliverables, including work performed internally and by CROs, to ensure quality, accuracy, traceability, and submission readiness of clinical data and analysis outputs.
• Supports and contributes to CDISC and client standards governance, including standardization initiatives, development or review of standards documentation, process documentation, guidance documents, templates, and associated training materials.
• Provides mentorship, knowledge sharing, presentations, and training to programmers and cross-functional stakeholders on CDISC standards, client standards, submission expectations, internal processes, SOPs, and best practices for standards implementation.
• Identifies process gaps, programming challenges, standards inconsistencies, and opportunities for improvement, and collaborates with Programming leadership and cross-functional partners to develop global tools, processes, and practices that improve efficiency, quality, and capacity within the Programming organization.

Skills

CDISC standards

Statistical programming

Leadership

Communication skills

Education

BSc/MSc/Diploma in CS/Math/Stats

Job description

Cytel is seeking a Principal Programmer CDISC SME to provide subject matter leadership across CDISC standards in clinical studies and regulatory submissions. You will work embedded within a global pharmaceutical client, ensuring SDTM, ADaM, CDASH, and define.xml deliverables meet regulatory expectations.

You will mentor teams, review datasets, collaborate with statisticians and CROs, and drive data standardization, quality, and submission readiness across programs with autonomy and ownership.