PK/PD Statistical Programmer (m/w/d) - homebased

Tasks

• Build and test automated validation suites for R packages
• Conduct QC for externally produced datasets
• Coordinate with cross functional teams to resolve data issues
• Create pre lock and post lock PKPD datasets
• Execute QC for NONMEM datasets
• Maintain SOP and regulatory compliance
• Perform data review and discrepancy resolution
• Prepare regulatory submission deliverables
• Program NONMEM ready PKPD datasets
• Support PM dataset standardization initiatives
• Validate SDTM ADaM based datasets

Perks/Benefits

• Homebased work
• Inspection Readiness Support

Skills/Tech-stack

ADaM | Clinical Data Analysis | Clinical data | Controlled Terminology | Data Analysis | Data Validation | Nonmem | PKPD | Package testing | Pharmacometics | QC automation | Quality Control | R | R Package Testing | Reproducible programming | SDTM