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Statistical Programmer I

China-Shanghai Shinmay

CNY 192K-233K (estimate) Mid-level Full Time

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Found 1d ago

Tasks

Contribute to process and quality improvement
Coordinate project start-up activities
Develop derived datasets
Ensure compliance with ICH GCP and 21 CFR Part 11
Maintain supporting documentation in accordance with SOPs and guidelines
Participate in internal external audits and regulatory inspections
Perform QC for derived datasets tables figures data listings
Produce SDTM ADaM tables figures data listings
Support production and QC of derived dataset specifications
Train and mentor staff on regulatory knowledge and SAS

Perks/Benefits

N/A

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Data Quality | Data quality control | Electronic submissions | ICH GCP | Part 11 | Process Improvement | Project documentation | Quality Control | Quality management | Regulatory Compliance | SAS | SDTM

Education

N/A

Roles

Programmer | Statistical Programmer

Regions

Countries

States

Cities

Shanghai, Shanghai, CN

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