Principal Biostatistician
USA IRV-17011 Redhill/DBC1-5, United States
USD 132K-186K Senior-level Full Time
Tasks
- Advise on clinical study conduct
- Analyze clinical endpoints
- Compile technical documents for internal external audits
- Coordinate analyses for study reports and documents
- Develop and ensure clinical database data quality
- Develop biostatistics SOPs and work instruction manuals
- Develop case report forms and database for quality data collection
- Lead data analysis for data monitoring committees
- Lead statistical analysis for clinical trials
- Provide ad hoc statistical analysis
- Provide statistical expertise for product development and regulatory submissions
- Provide statistical programming and validation support
- Represent biostatistics on project teams
- Support publication and presentation efforts
- Support regulatory documents
Perks/Benefits
- N/A
Skills/Tech-stack
Access | Bayesian analysis | Biostatistics | Clinical Trial Design | Clinical trial | Data Analysis | Data Quality | Data Validation | Data quality assurance | Database Development | Excel | FDA Regulations | GCP | ICH Guidelines | ISO Standards | MS Office | PowerPoint | Quality Assurance | R | SAS | Statistical modeling | Statistical programming | Trial design | Word
Education
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