Principal Statistical Programmer FSP
Tasks
- Create maintain and validate programming tool and macro standards
- Develop CRFs, edit checks, and data validation plans
- Develop SAS programs for datasets, listings, tables, and graphs
- Develop validate and maintain SAS and R programs
- Follow FDA regulations and electronic submission guidelines
- Generate SDTM and ADaM specifications
- Oversee CRO statistical programming deliverables
- Prepare clinical study reports and regulatory submissions
- Review and author SOPs and work instructions
- Support data transfer specifications
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CRF | Clinical Data Validation | Clinical data | Clinical trial | Data Transfer Specification | Data Validation | Data transfer | Define.xml | Edit Check | FDA Regulations | ICH | ICH GCP | Medical terminology | R | S&OP | SAS | SDTM | TLF | Work instructions
Education
N/A
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