Principal Programmer (Data Oversight & Standards) provides leadership and oversight for clinical data build, programming, and vendor deliverables across in-house, hybrid, and outsourced studies, ensuring alignment with CSL standards, regulatory requirements, and industry best practices.
Requirements
- Leads and develops a team of Clinical Data Validation Programmers, providing direction on clinical data standards, validation, and oversight activities across in-house, hybrid, and vendor-supported studies.
- Establishes and drives clinical data governance frameworks, including review and validation processes for eCRF builds, SDTM datasets, specifications, and vendor deliverables, ensuring compliance with internal standards, regulatory requirements, and industry best practices.
- Oversees the development, implementation, and continuous improvement of clinical data standards (e.g., CDASH, SDTM) and associated validation check libraries to enable consistent, scalable, and high-quality data across studies.
- Provides strategic oversight of data integration processes, including external data flows and system interfaces, ensuring accurate, efficient, and compliant data ingestion into downstream platforms such as the Clinical Data Warehouse.
- Ensures submission readiness of clinical data by establishing robust quality control frameworks and validation processes aligned with regulatory expectations (e.g., SDTM, ADaM, define.xml).
- Develops, maintains, and governs departmental and cross-functional SOPs, standards, and QMS documentation related to clinical data oversight, standards, and programming.
- Drives cross-functional alignment by partnering with Biostatistics, Data Management, Standards, and external partners to ensure consistent understanding and application of clinical data standards and quality expectations; provides guidance, knowledge sharing, and targeted training to support effective implementation across studies.
- Provides oversight and guidance on data storage, archival, and retrieval strategies to support regulatory submissions, pooled analyses, and reuse of legacy data in collaboration with Biostatistics and other stakeholders.
- Oversees programming and validation support to ensure availability of high-quality, analysis-ready datasets, while promoting automation, efficiency, and innovation through the use of SAS and emerging technologies (e.g., Python, AI-driven solutions).
- Experience with CROs (either managing a CRO, or having worked in a CRO)
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
