About the Role
This role is responsible for leading clinical data programming activities across clinical development programs, including the development of datasets, tables, listings, figures, and data standards in alignment with regulatory requirements and internal processes.
Responsibilities
- Lead programming activities for clinical trial data, including raw data processing and analysis-ready datasets
- Develop and validate datasets, tables, listings, and figures for clinical study reports
- Collaborate with biostatistics and data management teams to define data specifications
- Ensure adherence to CDISC standards, including SDTM and ADaM
- Oversee programming timelines and deliverables across multiple studies
- Mentor and guide junior programming staff
- Review programming code for accuracy, efficiency, and compliance
- Support regulatory submissions by providing high-quality programming outputs
- Contribute to the development and maintenance of programming standards and best practices
- Work closely with cross-functional teams to resolve data-related issues
- Manage vendor programming teams and external deliverables
- Ensure consistency and traceability across programming artifacts
- Participate in study planning and protocol development from a programming perspective
- Support data review and database lock activities
- Develop and maintain shell tables for efficient reporting
- Implement automation strategies to improve programming efficiency
- Ensure compliance with SOPs, regulatory guidelines, and industry standards
- Participate in audits and inspections as a programming representative
- Stay current with evolving data standards and regulatory expectations
- Lead programming input for data transfer and integration initiatives
- Support data anonymization and disclosure requirements
- Contribute to the evaluation and adoption of new programming tools and technologies
- Assist in the preparation of programming-related documentation for regulatory submissions
- Ensure data integrity and consistency across all programming outputs
- Provide estimates and input for programming-related project planning
Why This Role Matters
This position plays a critical role in ensuring the accuracy and reliability of clinical data used to support regulatory decisions and drug development. The work directly impacts the quality of submissions and the speed at which therapies reach patients.
What We Value
We prioritize technical excellence, collaboration, and a commitment to patient-centered innovation. Candidates should demonstrate initiative, attention to detail, and the ability to lead in a dynamic, science-driven environment.
