Executive Director, Biostatistics
Bayside Solutions · San Mateo County, CA · 3 wk ago
HybridResearch$125–$135/hrFull-time
About the role
Direct hire, full‑time position located in Redwood City, CA with a hybrid work arrangement.
Responsibilities
- Support clinical trials and assure well‑designed studies.
- Provide statistical expertise for design, analysis, interpretation, and communication of trial results.
- Perform statistician duties for regular clinical trials within national or international development projects as required.
- Collaborate with Trial Clinical Monitor and trial teams in planning clinical protocols conforming to company and regulatory agency guidelines.
- Support statistical methodology sections for protocols and Statistical Analysis Plans (SAPs) and author TFL shells.
- Analyze data from Phase I‑III trials, including TFL shell development and responsibility for program validation.
- Review and evaluate proposed case report forms for consistency with protocol information needs.
- Review randomization procedures for clinical trials.
Requirements
- Ph.D. in Statistics, Biostatistics, Biometry, or a related quantitative field.
- 5+ years of relevant experience.
- Demonstrated experience designing, conducting, analyzing, and/or presenting clinical trials or research studies, including applying statistical methodologies to research questions.
- Proficiency in SAS and/or R programming.
- Thorough knowledge of statistical methodology, clinical trial design, and clinical trial data processing and analysis.
- Strong written and verbal communication skills, with ability to collaborate across cross‑functional teams.
- Strong attention to detail and commitment to quality, accuracy, and timely completion of deliverables.
Skills
- Clinical Biostatistics
- Clinical Trial Design
- Phase I‑III Clinical Trials
- Statistical Analysis
- Statistical Methodology
- Statistical Analysis Plans (SAPs)
- TFL Development
- TFL Shells
- SAS
- R
- Clinical Data Analysis
- Statistical Programming
- Program Validation
- Protocol Development
- CRF Review
- Randomization
- Clinical Trial Data Processing
- Data Interpretation
- Clinical Research
- Regulatory Guidelines
- Cross‑Functional Collaboration
- Statistical Reporting
- Quality Control
- Data Accuracy
- Scientific Communication
Pay
Pay rate: $125 – $135 per hour.