Poseida Therapeutics, Inc. is seeking a talented Director, Biostatistics to join our team in San Diego, CA. This position offers an excellent opportunity for a highly motivated individual to contribute to innovative clinical trials for new CAR-T, gene editing and gene therapy products in an exciting and dynamic environment focused on cutting-edge gene editing technology. The Director, Biostatistics will be responsible for leading and managing all statistical design and analysis activities related to clinical trials and exploratory biomarker research programs. This position will have oversight of final delivery of data for clinical study reports, publications, and regulatory submissions. This role will be accountable for the oversight of outsourced statistical activities and for managing internal staff and processes.
• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications.
• Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and regulatory authorities statistical and data requirements.
• Collaborates with programming, data management, and clinical operations functions to ensure data collection, cleaning, and reporting is done in conformance with ongoing practice and regulatory expectations.
• Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data and implications for study design.
• Provides statistical subject matter expertise to the clinical and project teams as appropriate; Liaise with non-clinical and pre-clinical teams regarding the conduct of experiments, statistical methodology, and data analysis and interpretation.
• Assume responsibility for statistical components of regulatory submissions; ensure that all activities are conducted in compliance with relevant regulatory requirements.
• Review clinical study protocols, providing statistical feedback and input on project design, endpoint definition and sample sizes; provide sample size calculations and documentation.
• Provide statistical support of the strategic planning, authoring, and review of abstracts, manuscripts and other scientific data disclosures.
• Supervise Biostatistics-related work conducted by relevant external consultants and clinical research organizations.
• Ensure table, listing, figure and statistical analysis programming is being done according to specifications.
• Coordinate contract vendors and Clinical Research Organization statistical related activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
• PhD Biostatistics
• 10+ years’ biostatistics experience in biotech, pharma, or CRO setting, including previous experience managing others.
• Experience analyzing data from oncology clinical trials.
• Experience analyzing multiple myeloma trial data preferred.
• Experience managing and analyzing chimeric antigen receptor cell (CAR-T) data preferred.
• Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and other applicable international regulations and guidelines.
• Advanced proficiency in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS and other relevant statistical software.
• Advanced understanding of the development, programming, management, validation and documentation maintenance of all programming tasks.
• Demonstrated experience leading change implementations using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC, including development of SDTM and ADaM specifications.
• Significant experience using MS Office including Project, Excel, PowerPoint required; experience with SharePoint and Spotfire highly preferred.
• Working knowledge of Good Clinical Practices (GCP), ICH, and US and international regulations.
• Ability to travel up to 10%.
• Ability to deliver results and execute on required activities individually and in a team setting.
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology