Statistical Programmer II
Tasks
- Assist in coordinating project start up activities
- Assist in production and QC of derived dataset specifications
- Check own work for first-time quality
- Create global programs and tracking spreadsheets
- Deliver high quality statistical programming services
- Develop knowledge of SAS and internal processes
- Ensure compliance with SOPs and ICH-GCP
- Ensure compliance with technical standards like CDISC and electronic submissions
- Maintain regulatory knowledge for clinical industry
- Maintain supporting documentation in accordance with SOPs and guidelines
- Participate in audits and regulatory inspections
- Participate in process and quality improvement initiatives
- Produce derived datasets, tables, figures, and data listings
- Provide training and mentorship to staff and project teams
- QC low to medium complexity derived datasets tables figures and data listings
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | ICH GCP | Part 11 | S&OP | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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