Arcus Biosciences is seeking a clinical biostatistician with broad responsibility for providing high-quality statistical expertise to assigned clinical studies and projects at Arcus. He or she will look beyond the purely statistical aspects, collaborating to promote rigor in the planning, conduct, and analysis of experiments, as well as to guide the interpretation and reporting of results.
The position will report into the Head of Biometrics and will interact regularly with a diverse group of internal and external stakeholders. Demonstrated ability to prioritize work and to effectively communicate with collaborators both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.
This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with industry knowledge and be able to quickly integrate into clinical study teams. At the same time, the ideal candidate will also have interest and experience in conducting or leading exploratory data analyses involving diverse data types.
Job Duties and Responsibilities
Serves as a biostatistics representative on clinical development teams and strategically partners with other functions in the planning, design, analysis, and reporting and communication of results (internally and externally) from clinical studies in all phases of development
Develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs potentially addressed via their statistical toolset
Ensures data and analysis quality including the oversight of any external statistical vendors, contractors or consultants when generating formal or informal tables, listings and figures
Appropriately adopts or develops innovative statistical methods to solve scientific questions, support decision making, or guide product or process improvements
Builds solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders
Keeps abreast of new developments in statistics, drug development and regulatory guidance and requirements through literature review and professional activities
Continuously demonstrates an interest in learning, including eagerness and comfort taking on unfamiliar tasks or working with new types of data (e.g., PK/PD data, biomarker data, real world or registry data, etc.)
PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience
Minimum 3+ (Senior Statistical Scientist) or 6+ (Associate Director) years of biotechnology or pharmaceutical industry experience
Sound understanding of theoretical and applied statistics
Fluency with standard statistical software (SAS or R)
Strong analytical skills and demonstrated experience in gathering, analyzing, interpreting, reporting and presenting data
Knowledge of industry standards for clinical data collection and data base structure, e.g., CDISC guidelines for SDTM and ADaM data sets for both CRF and non-CRF data
Ability to work independently on multiple projects, anticipate challenges and defend positions based on science and sound data analysis
Ability to effectively communicate statistical concepts to non-statisticians
Takes a fit-for-purpose mindset to daily work as well as long-term vision
Experience in oncology or immunology will be a strong plus as will any specialty expertise related to one or more partner functions, e.g., preclinical or translational research and development, bioinformatics, CMC/manufacturing, etc.
Experience with observational data analysis, including but not limited to real-world data (RWD) or patient-reported outcome (PRO) data, will also be a plus
Arcus Biosciences, Inc.