SENIOR ASSAY BIOSTATISTICIAN

Employer
Location
Menlo Park, California
Salary
Commensurate with experience
Posted
May 23, 2017
Closes
Jul 23, 2017
Category
Informatics
Hours
Full Time

SENIOR ASSAY BIOSTATISTICIAN

Clinical Development and Medical Affairs

GRAIL, Inc., is a discovery-stage life sciences company that is developing differentiated platforms for the early detection of cancer. GRAIL’s research programs combine approaches to ultra-deep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL’s software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.

POSITION SUMMARY

The Senior Assay Biostatistician provides statistical expertise and statistical solutions for development of our GRAIL assay and to ongoing process monitoring of the assay in the clinical lab.

TASKS AND RESPONSIBILITIES

  • Contribute to analytical validation strategies for the GRAIL assay.
  • Collaborate with internal stakeholders in the design, analysis, interpretation, and publication of analytical studies.
  • Write protocols, statistical analysis plans, study reports, and contribute to presentations of analytical studies.
  • Establish and document QC specifications for controls and patient specimens, in-process testing, reagent and sample stability studies, and reagent and instrument qualification.
  • Establish acceptance criteria for proficiency testing (PT) and correlation testing.
  • Develop, implement, and document statistical process monitoring tools.
  • Statistical evaluation and documentation of process monitoring, correlation testing, and troubleshooting.
  • Stay abreast of industry and academic developments in the statistical genomics field and regulatory guidelines and apply to analytical study design and analysis.

PREFERRED BACKGROUND

  • 5+ years of experience in academia or industry.  Molecular diagnostics industry experience required.
  • PhD in statistics or equivalent.
  • Strong knowledge of theoretical and applied statistics.
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA, and CLIA.
  • Strong expertise programing in R.
  • Strong team player with demonstrated track record of success in cross-functional team environment.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.