Company DescriptionCareDx 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.Job DescriptionTitle Staff BiostatisticianManager Sr. Director Research and DevelopmentFLSA ExemptClassification Regular Full TimeDepartment Research amp DevelopmentLocation Brisbane HQManagement 2 3 full time amp contract staffGeneral DescriptionWe 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 developmentvalidation 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 ManufacturingProcess Development.Responsibilities as follows but not necessarily limited toContribute statistical and bioinformatics expertise and guidance to all studies conducted by the clinical research development and operations departmentsCell free DNA test development using next generation sequencing technologiesDiagnostic test quality control development and test system statistical monitoringClinical study design and analysis including detailed sample selection from existing archives and design of de novo studiesDesign and support multiplex gene expression diagnostic algorithmsContribute to regulatory submissions and responsesPlay 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 neededConsult with research and development labs commercial lab and clinical development on use of proper experimental design methods and statistical techniquesManage personnel allocate resources to cross functional initiatives and manage departmental budgets.QualificationsPh.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 technologiesMinimum 5 8 years experience working in the in vitro diagnostics field LDT andor test kits at least 2 years in a supervisory roleExpert in R SAS or other statistical software packagesExperience with gene expression proteomic genetic or other genomic data sets desiredExperience using optimal experimental design techniques is a plusStrong desire and proven ability to work collaboratively and cross functionally on new product development teams departmental projects and company initiativesStrong 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.Additional InformationAll your information will be kept confidential according to EEO guidelines.Sorry this job has expired