- Perform clinical and statistical programming activities for clinical trials throughout the full study life cycle.
- Review clinical trial protocols, SAPs, CRF designs, and EDC deployments, and provide input for EDC edit checks.
- Guide and review CRO outputs, including submission datasets, programs, specifications, TLFs, define.xml, and reviewer guides.
- Execute and support programming activities for IND, NDA, and/or BLA regulatory submissions.
- Review data management plans and data transfer plans, and test EDC deployments for downstream programming readiness.
- Provide hands-on SAS programming for safety and efficacy analyses, exploratory analyses, and publication analyses.
- Provide technical oversight to statistical and data programmers and contractors as needed.
- Collaborate with biostatistics, data management, clinical operations, study physicians, and safety review teams to address data and programming issues.
- Support audits, inspections, and regulatory inquiries related to statistical programming deliverables.
- Help build biometrics infrastructure, including macros, programs, TLF shells, SOPs, and programming and data traceability practices.
GCPR