Associate Director/Director, Biostatistics

Location
Hayward, CA, United States
Posted
Sep 15, 2020
Ref
104
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Position

Arcus Biosciences is seeking a(n) (Associate) Director of Biostatistics with broad responsibility for providing high-quality statistical expertise to assigned clinical 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 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.

The (Associate) Director of Biostatistics will operate at the program- and study-levels, with the exact disease areas and molecules to be matched on prior experience and interest. All disease areas span multiple stages and phases of development, including both early proof-of-concept studies as well as late-stage clinical trials.

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 come with industry experience and be able to quickly integrate into teams as well as to contribute to the growth, buildout and infrastructure of the Biometrics department.

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 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
  • Anticipates and communicates internal and external resourcing needs to ensure milestones at every level are successfully achieved


Qualifications

Education/Experience
  • PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience
  • Minimum 6+ (Associate Director) or 9+ (Director) years of biotechnology or pharmaceutical industry experience
  • Sound understanding of theoretical and applied statistics
  • Fluency with standard statistical software (SAS or R). R programming skills a plus.
  • 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 as well as experience with health authority submissions


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
  • Experience in late-stage oncology development a plus
  • Experience and interest in exploratory or observational data analysis, including but not limited to translational/biomarker data analysis, real-world data (RWD) or patient-reported outcome (PRO) data, will also be a plus