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Form of workCareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next-generation sequencing, to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. For more information, please visit: www.CareDx.com.
Title: Senior Director, Biostatistics
Manager: Chief Scientific Officer
FLSA: Exempt
Classification: Regular Full Time
Department: Research & Development
Location: Brisbane (HQ)
Management: 4-5 full time & contract staff
General Description
We are seeking a highly motivated, experienced and skilled biostatistician with a wealth of experience in the diagnostics industry to fill the critical role of Senior Director, Biostatistics. The position is responsible for setting strategy and tactics for applying statistical 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 Senior Director, Biostatistics will provide statistical guidance to various projects and initiatives throughout the company. This is a highly interactive and broad responsible technical leadership role having key interfaces beyond R&D with personnel involved in clinical research, medical informatics, commercial laboratory operations, instrument automation, manufacturing, engineering, and software development.
Responsibilities as follows, but not necessarily limited to:
Contribute statistical expertise and guidance to all studies conducted by the clinical, research, development, and clinical reference laboratory groups
o Cell-free DNA test development using next-generation sequencing technologies
o Diagnostic test quality control development and test system statistical monitoring
o Clinical study design and analysis including detailed sample selection from existing archives and design of de novo studies
o Design and support multiplex gene expression diagnostic algorithms
Propose and provide support for established and emerging statistical tools
Develop automated biostatistical analysis pipelines for staff with different levels of understanding of biostatistics
Contribute to regulatory submissions and responses
Play a key role in experimental, registry and trial design 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
Review statistical approaches described in high impact peer-reviewed papers
Manage personnel, allocate resources to cross functional initiatives, and manage departmental budget
Ph.D. in statistics, mathematics, computational methods, or a related discipline or equivalent experience. Additional training or degree in biochemistry, molecular biology, or immunology would be considered an added benefit.
Minimum 10-12 years experience working in the in vitro diagnostics field (LDT and/or FDA regulated); at least 5 years in a supervisory role
In-depth familiarity with established (sensitivity, specificity, accuracy, NPV, PPV, AUC (ROC), etc.) and emerging (Bayes pre- and post-test probability, reclassification indices, etc.) diagnostic statistical tools
Expert in R, SAS and other statistical software packages
Experience in analysis of high-throughput next-generation sequencing and gene expression data (e.g. microarrays, RNA-Seq, etc.)
Experience using diverse and fit-for-purpose experimental design techniques required
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
Solid problem solving skills
Strong presentation skills
Experience managing professional staff with various ranges of experience
Benefits & Perks: We provide Medical, Dental, Vision and Life Insurance, Flexible Spending and Dependent Care Accounts, Commuter Accounts, 401(k), 3 weeks of vacation, 5 days sick leave, 1 personal floating holiday, 9 paid holidays, gym reimbursement, yoga onsite, ping pong, foosball, BBQ's, social hours, and more!
