Senior/Principal Statistical Programmer FSP (Remote)
Tasks
- Author data transfer specifications
- Create define xml files
- Create review and author SOPs and work instructions
- Develop CRFs edit check specifications
- Develop SAS programs for datasets
- Develop SAS programs for listings tables and graphs
- Develop and validate R programs
- Develop data validation plans
- Develop validate and maintain SAS programs
- Develop validate programming tool standards and macros
- Follow FDA regulations
- Follow Good Clinical Practice
- Generate ADaM specifications
- Generate SDTM specifications
- Oversee CRO statistical programming deliverables
- Perform exploratory analyses
- Prepare clinical study reports
- Support DSUR
- Support publications
- Support regulatory submissions
Perks/Benefits
Skills/Tech-stack
ADaM | CDISC | CRF | Clinical Practice | Clinical Trial Methodology | Clinical data | Clinical data standards | Clinical trial | Data Standards | Data Validation | Define-XML | Edit checks | FDA Regulations | GCP | Git | Good Clinical Practice | ICH | Medical terminology | Pharmacokinetic data | Pharmacokinetics | R | SAS | SDTM | SOP Development | Trial methodology | Unix/Linux
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
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