Principal Statistical Programmer FSP
Tasks
- Create maintain document and validate programming standards and macros
- Create reviewer guide and define xml
- Develop CRFs edit check specifications and data validation plans
- Develop SAS programs for listings tables and graphs
- Develop validate and maintain SAS and R programs
- Ensure reporting outputs meet timelines and quality standards
- Follow FDA regulations and good clinical practice
- Generate SDTM, ADaM specifications and datasets
- Oversee CRO statistical programming deliverables
- Review and author SOPs and work instructions for statistical programming
- Review and author data transfer specifications
- Support clinical study reports and regulatory submissions
- Support publications and annual DSUR and exploratory analyses
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Development | Clinical Practice | Clinical Trial Methodology | Clinical trial | Data Validation | Data transfer | Data transfer specifications | Define.xml | Edit checks | Electronic submissions | FDA | Git | Good Clinical Practice | ICH | Medical terminology | R | S&OP | SAS | SDTM | Statistical programming | Trial methodology | Unix/Linux
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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