Senior Director, Biostatistics
Location: Brisbane, CA
Work Mode: On-site (Headquarters)
Company: CareDx, Inc.
Job Type: Full-Time
Department: Research & Development
Reports to: Chief Scientific Officer
Manages: 4–5 full-time and contract staff
Job Summary
CareDx, a leader in molecular diagnostics for transplant recipients, is seeking an experienced and innovative Senior Director, Biostatistics. This pivotal role will shape biostatistical strategies across R&D, clinical studies, and diagnostic product development. As a key contributor to cross-functional initiatives, you will lead statistical approaches for NGS-based assays, gene expression tests, and regulatory submissions in the in vitro diagnostics (IVD) space.
Key Responsibilities
Lead biostatistical strategy for diagnostics R&D and product development
Oversee statistical analysis for studies involving cell-free DNA, NGS, and gene expression data
Design clinical studies, multiplex diagnostic algorithms, and QC systems
Guide experimental design and statistical methods across departments
Develop automated statistical pipelines and internal tools
Support regulatory submissions and scientific publications
Review statistical methods in peer-reviewed research
Manage and mentor a high-performing biostatistics team
Collaborate with cross-functional groups including engineering, medical informatics, and lab ops
Allocate resources and manage departmental budget
Required Skills & Qualifications
PhD in Statistics, Mathematics, Computational Methods, or related discipline
10–12+ years of experience in in vitro diagnostics (LDT and/or FDA regulated)
Minimum 5 years in a supervisory/leadership role
Proficiency with R, SAS, and other statistical software
Expertise in high-throughput NGS and gene expression data analysis (e.g., RNA-Seq)
Familiarity with diagnostic tools: sensitivity, specificity, PPV, NPV, AUC, Bayes, etc.
Strong communication skills for both technical and non-technical audiences
Experience with fit-for-purpose experimental design
Strong interpersonal, presentation, and mentoring abilities
Perks & Benefits
Medical, Dental, Vision, and Life Insurance
FSA, Dependent Care, and Commuter Accounts
401(k) retirement plan
3 weeks paid vacation, 5 sick days, 1 floating holiday
9 company-paid holidays
Gym reimbursement, onsite yoga
Ping pong, foosball, BBQs, social hours, and more
Company Description
CareDx, Inc. is a molecular diagnostics company headquartered in Brisbane, CA. Focused on transplant recipient care, CareDx develops high-value, non-invasive diagnostic surveillance tools using cutting-edge technologies like next-generation sequencing and gene expression profiling. The company is a leader in post-transplant care innovation with a growing pipeline and commercial success in heart and kidney diagnostics.
Work Mode
On-site at CareDx Headquarters, Brisbane, California
Call to Action
Ready to drive innovation in transplant diagnostics and lead biostatistical advancements at the forefront of molecular medicine? Apply today to join CareDx and help shape the future of precision diagnostics.
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