Principal Statistical Programmer FSP
Tasks
- Collaborate with internal and external teams
- Create and validate programming standards
- Develop CRFs and validation plans
- Develop SAS programs for data and report generation
- Ensure compliance with FDA regulations
- Generate SDTM, ADaM specifications and datasets
- Oversee CRO programming deliverables
- Review SOPs and work instructions
- Review external vendor data transfer specifications
- Support clinical study report preparations
Perks/Benefits
Skills/Tech-stack
CDISC standards | Clinical trial | Clinical trial methodologies | Data Transfer Specification | Data Validation | Data transfer | FDA Regulations | Macro development | Program validation | R | Regulatory Submission | Regulatory submission support | SAS | Submission support
Education
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