Principal Biostatistician
IND-Hyderabad-Hybrid, India
R
INR 2263K-4184K (estimate) Senior-level Full Time
Tasks
- Attend regulatory agency meetings
- Conduct statistical training
- Conduct verification and quality control
- Contribute to proposals and budgets
- Create programming specifications
- Create randomization schedule
- Develop statistical analysis plans
- Direct biostatistics project activities
- Implement SOPs and work instructions
- Mentor biostatisticians
- Oversee training plans
- Participate in DMC activities
- Participate in DSMB activities
- Prepare mock up tables listings figures
- Prepare project documentation
- Provide independent review
- Review SAS annotated case report forms
- Review database design
- Support regulatory submission analysis
- Support statistical tasks protocol to CSR
Perks/Benefits
Skills/Tech-stack
Analysis Plan | Biostatistics | Clinical data | Clinical trials | DMC | DSMB | Data Management | Data Monitoring | Data Monitoring Committee | Data Safety | Data Safety Monitoring Board | Data safety monitoring | ICH Guidelines | Programming specifications | Quality Assurance | Quality Control | Randomization | S&OP | SAS | SAS Macros | Statistical Analysis | Statistical Analysis Plan | Work instruction
Education
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