Associate Director, Biostatistics
Lyell Immunopharma
16 days ago
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Hybrid role (Seattle, Washington or South San Francisco, California)
Strategic Leadership:
- Drive statistical strategies for clinical development plans (Phase 1–3), including protocol design and study endpoints.
- Develop and implement innovative statistical methods (e.g., adaptive designs, Bayesian methods, simulation) to enhance clinical trial efficiency.
Clinical Study Support:
- Own statistical analysis plans (SAPs), sample size calculations, and ensure quality of tables, figures, and listings (TFLs).
- Oversee analysis of clinical data (and non-clinical as needed), interim analyses (including DMC meetings), result verification, and study report review.
- Ensure statistical deliverables are compliant, timely, and high-quality across all projects.
- Collaborate cross-functionally to deliver efficient, high-quality statistical outputs.
- Review/comment on eCRFs, annotated eCRFs, edit checks, and other clinical data management documents.
Regulatory Submissions:
- Provide statistical leadership for defined analyses, annual safety reports, information requests, and IND/BLA submissions to health authorities.
- Ensure compliance with regulatory requirements and guidelines for statistical programming.
Process Improvement:
- Apply advanced statistical modeling to solve challenging development questions; establish best practices.
- Identify process improvements to enhance quality of statistical deliverables.
- Create/acquire tools to improve biometrics efficiency.
Vendor Management:
- Collaborate with external vendors for statistical services, ensuring quality and timeline adherence.
Communication and Collaboration:
- Communicate statistical strategies, updates, and progress to executive leadership and cross-functional teams.
Preferred Education:
- PhD in Statistics, Biostatistics, Mathematics, or related field with 8+ years’ experience.
Preferred Experience:
- 10+ years in pharmaceutical industry or relevant regulatory environment; 5+ years preferred in cell/gene therapy.
- Leadership with a track record of scientific innovation in clinical development.
- Knowledge/experience with clinical development, GCP/ICH, global regulatory submissions, eCTD, and BLA/MAA/NDA; statistical methods for clinical trials, cell/gene therapy, and CMC data analysis; outsourced models.
Knowledge, Skills and Abilities:
- Strong technical/regulatory knowledge for statistical methodology in cell/gene therapy.
- Ability to lead and influence cross-functionally; manage multiple projects.
- Proficiency in R, SAS, Python and/or other statistical software.
- Strong analytical/problem-solving judgment; exceptional communication.
Compensation/Benefits:
- Salary range: $175,000–$200,000 annually; annual bonus opportunity; eligible for Lyell’s Equity Incentive Plan.
Application Instructions:
- Interested candidates should apply.
Strategic Leadership:
- Drive statistical strategies for clinical development plans (Phase 1–3), including protocol design and study endpoints.
- Develop and implement innovative statistical methods (e.g., adaptive designs, Bayesian methods, simulation) to enhance clinical trial efficiency.
Clinical Study Support:
- Own statistical analysis plans (SAPs), sample size calculations, and ensure quality of tables, figures, and listings (TFLs).
- Oversee analysis of clinical data (and non-clinical as needed), interim analyses (including DMC meetings), result verification, and study report review.
- Ensure statistical deliverables are compliant, timely, and high-quality across all projects.
- Collaborate cross-functionally to deliver efficient, high-quality statistical outputs.
- Review/comment on eCRFs, annotated eCRFs, edit checks, and other clinical data management documents.
Regulatory Submissions:
- Provide statistical leadership for defined analyses, annual safety reports, information requests, and IND/BLA submissions to health authorities.
- Ensure compliance with regulatory requirements and guidelines for statistical programming.
Process Improvement:
- Apply advanced statistical modeling to solve challenging development questions; establish best practices.
- Identify process improvements to enhance quality of statistical deliverables.
- Create/acquire tools to improve biometrics efficiency.
Vendor Management:
- Collaborate with external vendors for statistical services, ensuring quality and timeline adherence.
Communication and Collaboration:
- Communicate statistical strategies, updates, and progress to executive leadership and cross-functional teams.
Preferred Education:
- PhD in Statistics, Biostatistics, Mathematics, or related field with 8+ years’ experience.
Preferred Experience:
- 10+ years in pharmaceutical industry or relevant regulatory environment; 5+ years preferred in cell/gene therapy.
- Leadership with a track record of scientific innovation in clinical development.
- Knowledge/experience with clinical development, GCP/ICH, global regulatory submissions, eCTD, and BLA/MAA/NDA; statistical methods for clinical trials, cell/gene therapy, and CMC data analysis; outsourced models.
Knowledge, Skills and Abilities:
- Strong technical/regulatory knowledge for statistical methodology in cell/gene therapy.
- Ability to lead and influence cross-functionally; manage multiple projects.
- Proficiency in R, SAS, Python and/or other statistical software.
- Strong analytical/problem-solving judgment; exceptional communication.
Compensation/Benefits:
- Salary range: $175,000–$200,000 annually; annual bonus opportunity; eligible for Lyell’s Equity Incentive Plan.
Application Instructions:
- Interested candidates should apply.