Senior/Principal Statistical Programmer FSP (Remote)
Tasks
- Create CRFs and edit check specifications
- Create datasets listings tables and graphs
- Define and validate programming SOPs and work instructions
- Develop SAS and R programs
- Develop standards for programming tools outputs and macros
- Follow FDA regulations and good clinical practice
- Generate SDTM and ADaM specifications
- Maintain SAS and R programs
- Oversee CRO statistical programming deliverables
- Prepare exploratory analyses
- Review data transfer specifications
- Support clinical study reports and regulatory submissions
Perks/Benefits
Skills/Tech-stack
ADaM | Biostatistics | CDISC | CRF | Clinical Practice | Clinical data | Clinical data management | Clinical trials | Data Management | Data Validation | DefineXML | Edit checks | FDA Regulations | Good Clinical Practice | ICH | R | SAS | SDTM
Education
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