Senior Statistical Programmer Analyst Contractor
United States
R
USD 117K-180K (estimate) Senior-level Contract Full Time
Tasks
- Build and execute SAS programs
- Create and review SDTM mapping specifications
- Create and validate ADaM datasets
- Create and validate SDTM domains
- Define define.xml files
- Develop statistical programming specifications
- Execute internal data reviews
- Generate and validate TFLs
- Generate regulatory submission datasets
- Generate review guide
- Manage CRO delivery quality
- Manage CRO delivery timelines
- Plan and prioritize analytical deliverables
- Prepare exploratory analyses
- Prepare post hoc analyses
- Prepare regulatory review analyses
- Review case report forms
- Review data transfer specifications
- Review database specifications
- Support publications
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDASH | CDISC | CFR Part 11 | Clinical data | Clinical data standards | Controlled Terminology | Data Standards | DefineXML | Health Authority Reporting | ICH GCP | Part 11 | Python | R | SAS | SAS Macros | SDTM | TFLs | Unix
Education
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