Associate Director, Biostatistics
Lyell Immunopharma
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Strategic Leadership:
- Drive statistical strategies for clinical development plans (Phase 1–3), including protocol design and study endpoints.
- Develop and implement innovative statistical methods (adaptive designs, Bayesian methods, simulation) to enhance clinical trial efficiency.
Clinical Study Support:
- Own statistical analysis plans (SAPs), sample size calculations, and quality of tables, figures, and listings (TFLs).
- Oversee clinical (and non-clinical as needed) analyses, interim analyses (incl. data monitoring committee meetings), result verification, and review of study reports.
- Ensure statistical deliverables are compliant, timely, and high quality.
- Collaborate cross-functionally; review/comment on eCRFs, annotated eCRFs, and edit checks.
Regulatory Submissions:
- Provide statistical leadership for defined analyses, annual safety reports, information requests, and IND/BLA submissions.
- Ensure compliance with statistical programming regulatory requirements.
Process Improvement / Vendor / Communication:
- Apply advanced statistical modeling; promote best practices; identify improvements and create/acquire tools.
- Collaborate with vendors for statistical services.
- Communicate strategy and progress to executives and cross-functional teams.
Preferred Education:
- PhD in Statistics/Biostatistics/Mathematics (or related), 8+ years.
Preferred Experience / Knowledge & Skills:
- 10+ years in pharma or regulatory environment (5+ years preferred in cell/gene therapy).
- Leadership and innovation in clinical development; strong GCP/ICH, global regulatory submissions, eCTD, BLA/MAA/NDA exposure; R/SAS/Python proficiency; strong communication and analytical skills.
Compensation & Benefits:
- $175,000–$200,000 annually + annual bonus opportunity; eligible for Equity Incentive Plan.
Application Instructions:
- If you think you could fit, please don’t hesitate to apply.
- Drive statistical strategies for clinical development plans (Phase 1–3), including protocol design and study endpoints.
- Develop and implement innovative statistical methods (adaptive designs, Bayesian methods, simulation) to enhance clinical trial efficiency.
Clinical Study Support:
- Own statistical analysis plans (SAPs), sample size calculations, and quality of tables, figures, and listings (TFLs).
- Oversee clinical (and non-clinical as needed) analyses, interim analyses (incl. data monitoring committee meetings), result verification, and review of study reports.
- Ensure statistical deliverables are compliant, timely, and high quality.
- Collaborate cross-functionally; review/comment on eCRFs, annotated eCRFs, and edit checks.
Regulatory Submissions:
- Provide statistical leadership for defined analyses, annual safety reports, information requests, and IND/BLA submissions.
- Ensure compliance with statistical programming regulatory requirements.
Process Improvement / Vendor / Communication:
- Apply advanced statistical modeling; promote best practices; identify improvements and create/acquire tools.
- Collaborate with vendors for statistical services.
- Communicate strategy and progress to executives and cross-functional teams.
Preferred Education:
- PhD in Statistics/Biostatistics/Mathematics (or related), 8+ years.
Preferred Experience / Knowledge & Skills:
- 10+ years in pharma or regulatory environment (5+ years preferred in cell/gene therapy).
- Leadership and innovation in clinical development; strong GCP/ICH, global regulatory submissions, eCTD, BLA/MAA/NDA exposure; R/SAS/Python proficiency; strong communication and analytical skills.
Compensation & Benefits:
- $175,000–$200,000 annually + annual bonus opportunity; eligible for Equity Incentive Plan.
Application Instructions:
- If you think you could fit, please don’t hesitate to apply.