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Statistical Programmer II

Taiwan-Taipei

Mid-level Full Time

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Found 1mo ago

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

Roles

Programmer | Programmer II | Statistical Programmer | Statistical Programmer II

Regions

Countries

States

Cities

Taipei, Taiwan, TW

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