Clinical Development | San Francisco, Ca | Full Time
The Parker Institute for Cancer Immunotherapy (PICI) is radically changing the way cancer research is done. Founded in 2016 through a $250 million gift from Silicon Valley entrepreneur and philanthropist Sean Parker, the San Francisco-based nonprofit is an unprecedented collaboration between the country’s leading immunotherapy researchers and cancer centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. The institute also supports top researchers at other institutions, including City of Hope, Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, Icahn School of Medicine at Mount Sinai, Institute for Systems Biology and Washington University School of Medicine in St. Louis.
By forging alliances with academic, industry and nonprofit partners, PICI makes big bets on bold research to fulfill its mission: to accelerate the development of breakthrough immune therapies to turn all cancers into curable diseases.
Help us create a world that doesn’t fear cancer. Join us. www.parkerici.org
Overview of the Role
The Senior Biostatistician will be a technical lead responsible for the planning, execution, and interpretation of statistical analyses related to clinical trials and other projects across PICI. Essential functions will include partnering with the Clinical Development team to advise on study design and execution, and with the Informatics team to assist and advise in translational data analysis and interpretation. The Senior Biostatistician must be someone who has strong strategic thinking, communication, and team working skills.
Reporting Structure and Team
The Senior Biostatistician reports to the Director of Biostatistics and Data Management and is a key member of the Clinical Development team. We offer remote work with some visits to the San Francisco office Post COVID.
FLSA Status: Exempt
Essential Job Functions
- Ensure statistical integrity of analysis and reporting deliverables, including guidance on statistical methodology, optimization of study designs, endpoint selection and author/review statistical sections of the protocol, clinical study reports and related documents
- Conduct statistical analyses, sample size estimation, and create tools to gain useful insights from data as needed
- Proactively interface with Statistical Programming, Data Management, and other members of the Clinical Development and Informatics teams to understand the scope, priority, and timelines for each deliverable, and negotiating alternative timelines based on resourcing constraints
- Consult on methodologies for biomarker studies, bioinformatics analyses, and real-world data strategies
- Interpret, summarize and present data and statistical considerations to internal project teams, senior management, scientific advisory committees and health authorities
- Teach statistics basics and/or create standard tools and practices to enable colleagues to visualize and gain insights from their data
- Understand current trends in the design and statistical analysis of clinical trials, and identify new methods, tools, and techniques to drive innovation within the Clinical Development group
Knowledge, Skills, and Experience
- Ph.D in statistics, biostatistics, or a related field, or M.S. with relevant years of experience
- 3 to 6+ years of experience supporting clinical trials in an industry or academic environment. Experience with oncology, cell therapy, adaptive and/or early-stage clinical trials (Phase I/II) is a plus.
- Excellent knowledge of statistical theory including experimental design and survival analysis
- Minimum of 3 years’ experience with strong programming skills in R
- Ability to understand scientific questions and formulate appropriate statistical methods to test them
- Ability to support multiple projects in parallel
- Effective communication and collaboration skills (including statistical consulting skills, interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority and ability to build strong collaborative relationships with external partners)
- Familiarity with regulatory and research guidelines on drug development, GCP and statistical principles including ICH guidelines
- Experience working with biomarker data from high-dimensional molecular assays, such as flow cytometry and next-gen sequencing, is a plus