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Senior Director, Biostatistics

10-12 years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Full Time Education: PhD Skills:

 

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.