Principal Biostatistician (Biomarker Biostatistics Lead)
Tasks
- Act as primary statistical partner for clinical biomarker and translational teams
- Assess biomarker utility for exploratory pharmacodynamic prognostic predictive and surrogate
- Contribute to ALCOA++ compliant reporting and documentation
- Design and execute robust statistical analyses
- Develop tables listings figures and documented dashboards
- Ensure reproducibility traceability and data integrity of analyses
- Interpret results for clinical relevance and program decisions
- Lead biomarker biostatistics across clinical development programs
- Mentor promote and enforce reproducible R based analysis best practices
- Perform data quality control normalization and sensitivity analyses
- Provide statistical oversight for exploratory and translational biomarker analyses
- Represent biomarker biostatistics in governance crossfunctional and regulatory interactions
- Translate clinical questions into statistical objectives
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | ALCOA++ | Bioconductor | Biomarker Analysis | Biostatistics | CDISC | Clinical trials | Data Integrity | Data Visualization | Diagnostic Biomarkers | Event analysis | Git | Longitudinal analysis | Multiplicity adjustment | Normalization | Pharmacodynamic Biomarkers | Predictive Biomarkers | Prognostic Biomarkers | Python | Quality Control | R | R Shiny | Repeated Measures | Reproducibility | SAS | SDTM | Sensitivity Analysis | Spotfire | Statistical modeling | Surrogate Biomarkers | Survival analysis | Time to Event | Time to event analysis | Version control
Education
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