Associate Director, Biostatistics & AI
Tasks
- Apply Bayesian methods and adaptive designs
- Build test and iterate AI powered tools for drafting automation and anomaly detection
- Conduct statistical design analysis and reporting for clinical trials
- Design and implement AI ML interface environments
- Design statistical methodologies for medical insights
- Develop and maintain SOPs work instructions and best practices
- Develop estimands for clinical endpoints
- Establish maintain MLOps pipelines for model lifecycle
- Evaluate and deploy AI automation for CDISC mapping and submission prep
- Implement AI governance with explainability and bias assessment
- Integrate AI tools with EDC CTMS RTSM and pharmacovigilance systems
- Manage CRO statisticians and programmers
- Prepare regulatory submission statistics and respond to agency queries
- Set up validate and govern AI tooling in GxP environment
- Translate statistical and AI concepts into actionable insights
Perks/Benefits
- 401k employer match
- Company provided life and disability
- Comprehensive health care
- Employee stock purchase program
- Flex Spending Accounts
- Hybrid work model
- Mental health support
- Paid parental leave
- Paid professional development
- Pre-tax commuter benefits
- Remote work
- Subsidized lunch
- Unlimited flexible paid time off
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Adaptive Design | Annex 11 | Anomaly Detection | Artificial Intelligence | Bayesian Methods | Bias Assessment | Biostatistics | CDISC | CFR Part 11 | CTMS | Clinical trials | Define-XML | EDC | EU Annex 11 | Estimands | Explainable AI | GxP | Language Models | Large Language Models | Life sciences data | MLOps | Machine Learning | Model Deployment | Model Monitoring | Model Validation | Molecular Life Sciences Data | Part 11 | Pharmacovigilance | Prompt engineering | Python | R | RAG | RTSM | Regulatory Submissions | Retrieval-Augmented Generation | SAS | SDTM | SHAP | Statistical Analysis
Education
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