Principal Statistical Scientist, Oncology Biostatistics

Location
Remote or Hayward , California
Posted
Mar 26, 2021
Ref
192
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Position


Arcus Biosciences is seeking a Principal Statistical Scientist with broad responsibility for providing high-quality statistical expertise to assigned clinical studies and exploratory work 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 work directly with senior biostatisticians and will interact with a diverse group of internal and external stakeholders. The Principal Statistical Scientist initially will have statistical oversight responsibilities for clinical studies in our lung cancer and early oncology development spaces.

This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of (immuno-)oncology therapeutics. The ideal candidate will be motivated to integrate into clinical study teams, establish cross-functional partnerships, and have an interest in conducting exploratory data analyses involving new and diverse data types including, for example, exploratory or translational biomarker analyses in support of our clinical development plans.


Job Duties and Responsibilities


  • Serves as a biostatistician on clinical development teams and partners with other functions in the planning, design, analysis, and reporting and communication of results (internally and externally)
  • In partnership with senior statisticians, develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs addressed via their statistical toolset
  • Ensures data and analysis quality – including working with external statistical vendors, contractors or consultants – when generating formal or informal tables, listings and figures
  • Demonstrates a learning mindset by developing or adopting innovative, fit-for-purpose statistical methods, or tools to address scientific questions, engage in exploratory work, or support internal decision-making
  • Builds solid collaborations with cross-functional clinical 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


Qualifications


Education/Experience


  • PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience
  • 3+ years of biotechnology or pharmaceutical industry experience; clinical oncology experience is a strong plus
  • Sound understanding of theoretical and applied statistics
  • Fluency with standard statistical software (SAS or R). R programming skills a must.
  • 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


Professional/Personal Requirements


  • 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
  • Prior experience with biomarker data (especially routine companion diagnostic and/or next-gen sequencing data) and a firm understanding of biological assays is a strong plus
  • Subject matter knowledge in the areas oncology or immunology will be a strong plus as will any specialty expertise related to one or more partner functions, e.g., clinical pharmacology, preclinical or translational research and development, bioinformatics, CMC/manufacturing, etc.