CareDx, Inc. (formerly XDx, Inc.), based in Brisbane, California, is a publicly traded molecular diagnostics company focused on the discovery, development and commercialization of high value, non-invasive tests to enhance the care and long-term outcomes of transplant recipients. The company has commercialized AlloMap Gene Expression Profile Testing, which aids physicians in surveillance of heart transplant recipients.  CareDx, Inc. also is actively developing new tests for kidney transplantation.

Title:                            Staff Biostatistician

Manager:                     Sr. Director, Research and Development

FLSA:                         Exempt

Classification:             Regular Full Time

Department:                Research & Development

Location:                     Brisbane (HQ)

Management:              2-3 full time & contract staff

General Description 

We are seeking a highly motivated, experienced and skilled statistician with experience in the diagnostics industry to fill the role of Staff BioStatistican.  The position is responsible for setting strategy and tactics for applying statistical and bioinformatics techniques to the discovery of biomarkers and to play a key role in the development/validation of CareDx products in Solid Organ Transplantation.  In addition, the Staff Biostatistician will provide statistical and bioinformatics support and guidance to various projects and initiatives within the company. This is a highly interactive technical leadership role having key interfaces with personnel from Clinical Operations, Laboratory Operations, Technical Operations, and Manufacturing/Process Development. 

 Responsibilities as follows, but not necessarily limited to: 

• Contribute statistical and bioinformatics expertise and guidance to all studies conducted by the clinical, research, development, and operations departments
  • Cell-free DNA test development using next-generation sequencing technologies
  • Diagnostic test quality control development and test system statistical monitoring
  • Clinical study design and analysis including detailed sample selection from existing archives and design of de novo studies
  • Design and support multiplex gene expression diagnostic algorithms

• Contribute to regulatory submissions and responses
• Play a key role in experiment design and data analysis in support of internal and sponsored publications.
• Statistical analysis including analysis of complex genomic data sets, validation studies, discovery and development studies.  Identification, commissioning, and oversight of  sub-specialized consultants as needed   
• Consult with research and development labs, commercial lab and clinical development on use of proper experimental design methods and statistical techniques
• Manage personnel, allocate resources to cross functional initiatives, and manage departmental budgets. 

• Ph.D. in statistics, mathematics, computational methods, or a related discipline. Additional training or degree in biochemistry, molecular biology, or immunology would be considered an added benefit.
• Experience in analysis of high-throughput next-generation sequencing and gene expression via microarray, or other high-volume gene expression data generating technologies
• Minimum 5-8 years experience working in the in vitro diagnostics field (LDT and/or test kits); at least 2 years in a supervisory role
• Expert in R, SAS or other statistical software packages
• Experience with gene expression, proteomic, genetic or other genomic data sets desired
• Experience using optimal experimental design techniques is a plus
• Strong desire and proven ability to work collaboratively and cross functionally on new product development teams, departmental projects, and company initiatives
• Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non technical domains. The desire and ability to communicate and mentor is a key component of the role.
• Experience managing professional staff at senior and junior levels.