Statistical Programmer II
Tasks
- Assist in project start-up coordination
- Assist production and QC of derived dataset specifications
- Check own work to ensure first time quality
- Create ADaM tables figures and data listings
- Create SDTM tables figures and data listings
- Create global program documentation
- Deliver high quality statistical programming services
- Ensure compliance with SOPs guidelines ICH GCP and regulations
- Maintain supporting study documentation per SOPs and guidelines
- Participate in internal and external audits
- Perform QC for low to medium complexity derived datasets
- Proactively participate in process and quality improvement initiatives
- Produce derived datasets
- 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 | Data submission | Documentation Management | Electronic Data | Electronic data submission | ICH GCP | Part 11 | Process Improvement | Quality Control | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Related jobs
-
Mid-level Full TimeTaiwan-Taipei13h ago
-
Mid-level Full TimeTaiwan-Taipei2d ago
-
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
-
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