About the Role
The selected candidate will serve as a subject matter expert in CDISC standards and FDA submission compliance, supporting programming activities related to clinical data analysis and regulatory deliverables.
Responsibilities
- Lead the development and validation of datasets, tables, listings, and figures in compliance with CDISC standards
- Ensure clinical data deliverables meet FDA regulatory requirements for submission
- Provide expert consultation on CDISC implementation across therapeutic projects
- Collaborate with programming teams to standardize processes and improve data quality
- Review programming outputs for adherence to regulatory and client-specific specifications
- Support audit and inspection readiness for regulatory submissions
- Develop and maintain programming standards, macros, and validation procedures
- Advise on SDTM and ADaM dataset structure and content
- Troubleshoot complex data mapping and transformation issues
- Mentor junior programmers in best practices for regulatory compliance
- Participate in client meetings to clarify submission expectations
- Stay current with evolving FDA guidance and CDISC standards
- Ensure traceability from raw data to final submission deliverables
- Coordinate with data management and biostatistics teams to align deliverables
- Prepare documentation required for regulatory submissions
- Evaluate new tools and technologies to enhance submission efficiency
- Support cross-therapeutic area initiatives requiring standardized data outputs
- Contribute to process improvement initiatives within the programming department
- Assist in the validation of third-party or outsourced programming work
- Ensure consistency with agency-accepted formats for electronic submissions
Compensation
Competitive salary and benefits package
Work Arrangement
Remote
Team
Collaborative team environment with cross-functional project teams
Why This Role Matters
This position plays a critical role in ensuring that clinical data submissions meet the highest regulatory standards, directly impacting client success in gaining regulatory approval.
Growth Opportunities
Opportunities exist for professional development through involvement in high-impact submissions, innovation in data standards, and leadership in process optimization.
Not available
