Associate Director, Biostatistics

Benefits

Additional Information

Using living cells to treat - and sometimes even cure - cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This is a hybrid role and can be based out of our either our Seattle, Washington office OR our South San Francisco, California office. Strategic Leadership: Drive statistical strategies for clinical development plans (Phase 1-3), including protocol design and study endpoints. Develop and implement innovative statistical methods, such as adaptive designs, Bayesian methods, or complex simulation techniques to enhance clinical trial efficiency. Clinical Study Support: Responsible for statistical analysis plans (SAPs), sample size calculations, and ensure the quality of tables, figures, and listings (TFLs). This role will require both hands-on execution and the technical and strategic acumen to provide expertise to research and development projects. Oversee the analysis of clinical data (and non-clinical, as needed), interim analyses (including data monitoring committee meetings), verifying results, and reviewing study reports. Ensure statistical deliverables are conducted in a compliant and timely manner with high quality across all projects. Collaborate with cross-functional teams to ensure efficient and high-quality of the statistical deliverables. Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents. Regulatory Submissions: Provide statistical leadership to support execution of defined analyses, annual safety reports, information requests, and IND and biological licensing approval submissions to health authorities in the timely manner Ensure compliance with regulatory requirements and guidelines related to statistical programming. Process Improvement: Drive the application of advanced statistical modeling to solve challenging development questions. Promote a culture of scientific excellence and establishing best practices in statistical analysis. Work with other functional groups to identify opportunities for process improvements and enhanced quality of all statistical deliverables. Create or acquire tools to improve biometrics functional efficiency. Vendor Management: Collaborate with external vendors for statistical services, ensuring quality and adherence to project timelines. 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 fields with a minimum of 8 years' experience. PREFERRED EXPERIENCE: A minimum of 10 years relevant experience in the pharmaceutical industry, or relevant regulatory environment with a preference for at least 5 years of experience in cell and gene therapy areas. Strong leadership skills with a proven track record of scientific innovation in clinical development. Demonstrated experience and working knowledge in: Clinical development process GCP/ICH standards Global regulatory submission requirements eCTD format and content of regulatory filings with prior experience in BLA/MAA/NDA Statistical concepts and methodologies relevant to clinical trials, cell and gene therapy research and CMC data analysis. Experience in working with an outsourced model. KNOWLEDGE, SKILLS AND ABILITIES: Excellent knowledge of current technical and regulatory requirements related to statistical methodology in cell and gene therapy development. Effective leader and team member, with strong leadership capabilities to collaborate with cross-functional teams and to influence wh