Sr. Staff Biostatistician

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

About the role

We are seeking a highly motivated, experienced, and skilled statistician with experience in the diagnostics industry to fill the role of Sr. Staff Biostatistician. This position is responsible for setting strategy and tactics for applying statistical and bioinformatics techniques to the discovery of biomarkers and plays a key role in the development and validation of CareDx products in Solid Organ Transplantation. The Sr. 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 with key interfaces across Medicare Affairs, Clinical Operations, Laboratory Operations, Technical Operations, and Manufacturing/Process Development.

Responsibilities

• Co-lead research design and analytical strategies in clinical studies, including RCT, “pragmatic” trials, observational studies, and registries; outcomes research.
• Develop and execute complex analysis strategies, author/co-author reports, abstracts, and manuscripts, and provide statistical advice.
• Develop analytical pipelines and best practices to optimize efficiency and ensure high-quality, reproducible research with statistical rigor.
• Provide statistical expertise and guidance to cross-functional study teams.
• Represent Biostatistics in cross-functional initiatives, coordinating the scope and timeline for deliverables.
• Co-author study protocols, amendments, abstracts, and publications.
• Co-lead clinical study design in the context of product development and support performance claims.
• Develop statistical analysis plans and provide/supervise programming specifications for derived variables and analysis datasets.
• Independently perform statistical analyses and sample size calculations.
• Perform statistical ad hoc analysis and identify/report data issues or violations of study assumptions.
• Review derived datasets and all types of statistical analysis deliverables to ensure accuracy and internal consistency of reports and publications.
• Ensure that study results and conclusions are scientifically sound and clearly presented.
• Contribute to regulatory submissions and responses.
• Mentor junior team members and provide statistical consultation to R&D labs, commercial labs, and clinical development on proper experimental design methods and statistical techniques.
• Champion the adoption of AI-enabled analytical tools and workflows to improve efficiency, reproducibility, and quality of biostatistical analyses while maintaining scientific rigor and compliance.

Qualifications

• Ph.D. in statistics, mathematics, computational methods, or a related discipline. Additional training or degree in biochemistry, molecular biology, or immunology is a plus.
• Minimum 5-8 years of experience working in pharmaceutical, biotech, or a related industry.
• Expert in R, SAS, or other statistical software packages.
• 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.
• Experience managing or mentoring professional staff at senior and junior levels is desired.

Benefits

• Competitive base salary and incentive compensation.
• Health and welfare benefits, including a gym reimbursement program.
• 401(k) savings plan match.
• Employee Stock Purchase Plan.
• Pre-tax commuter benefits.
• Living Donor Employee Recovery Policy: up to 30 days of paid leave annually for full-time employees who donate an organ or bone marrow.

Pay

This is the anticipated base salary range for candidates who will work in Brisbane, California: $158,000—$205,000 USD. The final salary offered will depend on factors such as experience, education, and industry tenure. This role may also be eligible for additional discretionary bonuses, incentives, and restricted stock units.

For remote roles based in the United States (excluding the San Francisco Bay Area): $150,000—$195,000 USD.