Principal Biostatistician
El Segundo CA Mariposa, United States
USD 175K-205K Senior-level Full Time
Tasks
- Collaborate with cross functional teams on statistical approaches
- Create CDISC compliant analysis data structures
- Create and review statistical analysis plans
- Define randomization procedures
- Design interim analyses
- Develop SOPs and standardized templates
- Develop analysis datasets and statistical outputs
- Develop clinical trial protocols and clinical study reports
- Ensure analysis dataset traceability reproducibility and validation
- Lead data standardization activities
- Lead statistical strategy for clinical trials
- Maintain CDISC STDM and ADaM standards
- Manage electronic submissions to regulatory authorities
- Oversee statistical aspects from study design to regulatory submission
- Perform sample size calculations
- Provide mentoring and guidance to junior staff
- Support DMC activities
- Train junior staff in statistical methodology
- Write statistical methodology sections
Perks/Benefits
- 401k retirement plan with company match
- Employee assistance program
- Health and financial wellness programs
- Healthcare and dependent care flexible spending accounts
- Paid time off
Skills/Tech-stack
Adaptive trial design | Analysis Plan | Bayesian Methods | Biostatistics | CDISC ADaM | CDISC STDM | Clinical Practice | Clinical Research | Clinical Trial Design | Clinical trial | Good Clinical Practice | Interim analysis | NQuery | PASS | Randomization | Regulatory Submission | S&OP | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Trial design
Education
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Countries
States
Cities
Language: en
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