Principal Programmer, CDISC SME

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer expertise in CDISC across clinical trials, submissions, and activities related to standards.

• Interpret, implement, and manage CDISC standards, including CDASH, SDTM, ADaM, define.xml, annotated CRFs, Reviewer’s Guides, and associated submission documentation.

• Evaluate datasets, annotated CRFs, define.xml, Reviewer’s Guides, and CDISC-driven e-submission packages.

• Ensure precision, consistency, traceability, adherence to client standards, and alignment with regulatory requirements.

• Provide guidance to study teams, statisticians, programmers, Data Management, Technology Enabled Science, CROs, and other relevant parties.

• Design data structures and specifications for SDTM and ADaM datasets, tables, figures, listings, analysis submission materials, integrated summaries, and exploratory analyses.

• Lead or supervise the production, validation, and review of programming outputs generated internally and by CROs.

• Assist in the governance and standardization initiatives for CDISC and client standards.

• Create or assess standards documentation, processes, guidance, templates, and training resources.

• Provide mentorship, share knowledge, deliver presentations, and conduct training sessions.

• Identify gaps in processes and inconsistencies in standards, developing global tools, processes, and practices to enhance programming efficiency, quality, and capacity.

⛳️ Requirements

• Bachelor’s or Master’s degree in Computer Science, Mathematics/Statistics, or a related field.

• Over 7 years of experience in statistical programming within a CRO or pharmaceutical setting.

• Extensive practical experience with CDISC standards applied to clinical trial and regulatory submission outputs.

• Proven expertise in SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, controlled terminology, traceability, and regulatory submission expectations.

• Experience in reviewing, specifying, producing, validating, or overseeing CDISC-compliant datasets and submission packages.

• Strong comprehension of protocols, statistical analysis plans, data management plans, CRF builds, external data transfer specifications, dataset specifications, and analysis output requirements.

• Collaborative experience with statisticians, clinical programming teams, Data Management, Technology Enabled Science, Standards, study teams, and CROs.

• Excellent written and verbal communication abilities.

• Strong leadership and organizational capabilities.

• Aptitude to prioritize workloads for both individuals and teams.

• Proficiency in leading and collaborating across cross-functional, global teams.

• Experience in overseeing vendor deliverables while aligning with internal stakeholders.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.

• Ability to work with autonomy and ownership.

• Support from Cytel while being embedded with a pharmaceutical client.