Principal Statistical Programmer
IN025 Embassy Manyata Business Park, India
INR 3000K-4000K (estimate) Senior-level Full Time
Tasks
- Address project risks and escalate issues
- Apply FDA ICH guidelines and 21 CFR Part 11
- Collaborate with biostatistics data management clinical research regulatory affairs
- Contribute to continuous improvement of statistical programming processes
- Create global standard SAS macros
- Debug and resolve programming issues
- Develop ADaM specifications
- Develop SDTM specifications
- Ensure SAS programming complies with GCP regulations
- Ensure timely high quality programming results
- Lead statistical programming activities
- Maintain analysis data and reporting deliverables
- Manage SAS programming activities
- Manage internal resources and external vendors
- Mentor junior programmers
- Oversee adherence to protocols and statistical analysis plans
- Prepare and improve standard operating procedures
- Prepare data submission packages
- Provide expert direction for statistical programming design
- Support clinical studies programming
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Data Model | Analysis Plan | CDISC | CFR Part 11 | Clinical Data Standards Consortium | Clinical data | Clinical data standards | Data Model | ECTD | FDA | GCP | ICH | Integrated Summary | Integrated Summary of Efficacy | Integrated Summary of Safety | Part 11 | SAS | SAS Base | SAS Graph | SAS Macro | SAS Stat | SDTM | Statistical Analysis | Statistical Analysis Plan | Study Data Tabulation Model
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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