Statistical Programmer II
Tasks
- Coordinate project start-up activities
- Create global programs
- Deliver high quality statistical programming services
- Ensure compliance with SOPs and guidelines and ICH GCP
- Ensure first time quality through ongoing work checking
- Maintain supporting documentation per SOPs and guidelines
- Participate in internal and external audits and regulatory inspections
- Participate in process and quality improvement initiatives
- Produce derived datasets
- Produce tables figures and data listings
- Provide training and mentorship
- QC low to medium complexity derived datasets tables figures and data listings
- Support production and QC of derived dataset specifications
- Support regulatory submissions documentation
- Track spreadsheets and required documentation
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | ICH GCP | Part 11 | QC | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Related jobs
-
ADaM | CDISC | Clinical Trial Data | Clinical trial | Controlled TerminologyProfessional development | Remote work option | Written and verbal communicationSenior-level Full TimeTaipei , Taipei City, Taiwan R3d ago
-
Mid-level Full TimeTaiwan-Taipei22d ago
-
Senior Statistical Programmer I TWD 516K-612KADaM | CDISC | Clinical data | Clinical data management | Data ManagementHybrid work option | Remote work optionSenior-level Full TimeTaipei City, Taiwan, Republic of China R29d ago
-
Mid-level Full TimeTaipei, Taipei, Taiwan, Republic of China1mo ago