Principal Biostatistician
Americas, US-PA, King of Prussia, CSL Behring, United States
USD 151K-171K (estimate) Senior-level Full Time
Tasks
- Apply statistical methodologies to study design and data analysis
- Author statistical analysis plan for clinical trials and regulatory submissions
- Ensure CDISC TFL package for study report and regulatory submission
- Implement statistical strategies for clinical trials and regulatory submissions
- Interpret analysis results and ensure reporting accuracy
- Lead biostatistics in study design protocol development data collection data analysis reporting and submission preparation
- Lead statistical contribution to clinical development programs
- Manage outsourcing or internal statistical programmers and CRO deliverable review
- Provide statistical thought partnership for innovative study design and clinical development plans
- Support biostatistics interactions with regulatory authorities
Perks/Benefits
Skills/Tech-stack
Analysis Plan | Biostatistics | CDISC | CRO Management | Clinical trials | Data Analysis | Go No Go | Go No Go Criteria | Probability of technical success calculations | Programming collaboration | Protocol development | Regulatory Submissions | Statistical Analysis | Statistical Analysis Plan | Statistics | Study design | TFL
Education
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