Biometrics | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Position: Director, Biostatistics
Reporting directly to the Head of Biometrics, the Director of Biostatistics is accountable to provide hands on work and lead the biostatistics team to provide strategic, scientific, and statistical leadership to the assigned clinical development program(s). This position oversees statistical aspects of assigned projects to ensure that the assigned clinical development programs meet scientific, regulatory and quality requirements and are aligned with long-term development goals, through interactions with leaders of line functions supporting (e.g., Clinical development, Clinical Operations, Regulatory Affairs).
Responsibilities include but are not limited to:
- Provide statistical expertise to new drug development programs as a Subject Matter Expert in Biostatistics and statistical leadership in the design of clinical development plans
- Be the statistical leader and project manager accountable for all Biometrics deliverables for assigned product(s)
- Be a thought leader/expert in Oncology statistics, showing leadership/be the point of reference in statistical methods, regulatory guidelines (ICH, FDA, EMA, PMDA, CFDA, etc.), program strategies, clinical development planning and study designs in multiple Oncology indications
- Be a core member of the clinical team or the project team as representative for the Biostatistics and Programming functions to ensure coordination and alignment across Biometrics functions on program strategies and deliverables
- Manage, mentor and lead the team in study design, statistical analysis, and reporting of data and ensure the team contributes to development strategies for the assigned projects/studies that are aligned to the organizational goals, including innovative and relevant statistical designs, statistical expertise for regulatory documents and for key decisions and scientific communications
- Coordinate with other functional groups to ensure timeliness and quality of project deliverables and establish and maintain effective working relationships with vendors and project teams, including data management, statistical programming, clinical research, and corporate partners
- Ensure the quality of statistical input, show ability to integrate expertise across Biostatistics components (e.g., research, process development, translational research, clinical development, and regulatory, as well as from key opinion leaders and external statistical experts) into the assigned programs
- Accountable for production of the following study-related deliverables: appropriate sections of study protocols, study related charters, case report forms, statistical analysis plans, data unblinding plan, data analyses, manuscripts, and sections of clinical study reports and other registration documents
- Accountable for team’s statistical support aspects of assigned therapeutic areas including experimental design, protocol development, sample size estimation, statistical analysis plan development, patient randomization, case report form design, statistical analyses, and presentation of data
- Research and apply new statistical procedures as needed and initiate and drive innovation by implementing innovative and relevant designs in the support of program strategy
- Provides statistical input for regulatory submissions; responds to statistical questions raised by regulatory agencies and institutional review boards
- Other duties as assigned
Position Requirements & Experience:
- Ph.D. in statistics, biostatistics, or related field with at least 12 years of relevant experience or MS in statistics, biostatistics, or related field with at least 16 years of relevant experience as a project biostatistician in the biotech/pharmaceutical industry with at least 3 years of experience managing people
- Strong track record of developing statistical excellence and leading scientific improvement initiatives
- Expert knowledge in drug development process in Oncology, HA guidelines and submissions
- Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics, and statistical software packages, including SAS or R
- Experience with protocol development, clinical study reporting, ISS/ISE requirements, and regulatory submissions in paper and electronic format
- Ability to translate clinical study designs into statistical practice and educate study team members in the use of statistics
- Demonstrated ability to have managed a successful team as well as functional/multi-functional teams and/or initiatives
- Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.