Statistical Programmer II - South Africa (Home Based)

Tasks

• Adhere to E Submission standards and regulations
• Apply SDLC for programming deliverables
• Create Define xml
• Develop Reviewers Guides
• Ensure compliance with ICH and 21 CFR Part 11 requirements
• Generate tables listings and graphs from clinical trial databases
• Participate in project team
• Perform SAS programming for clinical trial deliverables
• Prepare BIMO outputs
• Support ADaM standards
• Support pooling of datasets for submissions
• Write SDTM specifications

Perks/Benefits

• Inclusive culture
• Supportive team
• Work from home

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | BIMO | CFR Part 11 | Clinical Trial Data | Clinical trial | Define-XML | E-submission | FDA | GCP | ICH | ISO 27001 | ISO 9001 | MS Office | Part 11 | Pooling | Reviewers Guides | SAS | SAS Base | SAS Macros | SDLC | SDSP | SDTM | Trial data