Principal Statistical Programmer
IN025 Embassy Manyata Business Park, India
INR 2500K-4000K (estimate) Senior-level Full Time
Tasks
- Contribute to continuous improvement of statistical programming processes and procedures
- Create SAS macros for efficiency
- Debug and troubleshoot programming issues
- Develop SDTM and ADaM specifications
- Develop and maintain analysis data and reporting deliverables
- Drive programming for clinical studies and regulatory submissions
- Ensure compliance with FDA and ICH guidelines
- Ensure programming complies with GCP and company procedures
- Lead statistical programming activities
- Manage SAS programming activities for clinical studies
- Manage internal resources and external vendors
- Mentor junior programmers
- Oversee adherence to protocols and statistical analysis plans
- Prepare data submission packages
- Provide expert direction on statistical programming design
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | ECTD | FDA Regulations | GCP | ICH Guidelines | Part 11 | SAS | SAS Base | SAS Graph | SAS Macro | SAS Stat | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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