Sr. Staff Biostatistician

CareDx, Inc.; Brisbane (CA); On-site; USD 158,000 - 205,000; Full time

Benefits offered by this job

Gym reimbursement

401(k) match

Employee Stock Purchase Plan

Pre-tax commuter benefits

Job summary

CareDx, Inc. is seeking a Sr. Staff Biostatistician to lead statistical and bioinformatics activities across solid organ transplantation programs. The role focuses on study design, analysis strategies for RCTs and observational studies, and guiding data science efforts with rigor and reproducibility.

The ideal candidate has a PhD in statistics or related field, 5–8 years in pharma/biotech, expert R/SAS skills, and a collaborative mindset to mentor staff and support regulatory submissions.

Qualifications

• PhD in statistics, mathematics, or computational methods.
• Experience in pharmaceutical/biotech industry is required.
• Expert in statistical software packages (R, SAS).

Responsibilities

• Co-lead study design and analytical strategies in clinical studies.
• Develop and execute complex analysis plans and publish results.
• Provide statistical expertise to cross-functional teams.
• Mentor junior staff and support regulatory submissions.
• Champion AI-enabled analytics in biostatistics.

Skills

R

SAS

Biostatistics

Education

PhD in statistics or related field

Tools

R

SAS

Job description

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. We are seeking a highly motivated, experienced and skilled statistician with experience in the diagnostics industry to fill the role of Sr. Staff Biostatistician. 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 development/validation of CareDx products in Solid Organ Transplantation. In addition, 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 having key interfaces with personnel from 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, registries; outcomes research.
• Develop and execute complex analysis strategies, author/co-author reports, abstracts and manuscripts and provide statistical advice
• Develop analytical pipeline and best practice to optimize efficiency and ensure high quality reproducible research with statistical rigor
• Provide statistical expertise and guidance to cross-functional study team
• Represent Biostatistics in cross-functional initiatives, coordinate the scope and timeline for the deliverables
• Co-author study protocol, amendments, abstracts, publications
• Co-lead in the clinical study design in the context of product development and support the performance claim
• Develop statistical analysis plans. Provide and supervise the programming specifications for derived variables and analysis datasets.
• Independently perform statistical analyses
• Perform sample size calculations
• Perform statistical ad hoc analysis.
• Identify and report data issues or violations of study assumptions.
• Review derived datasets and all types of statistical analysis deliverables.
• Ensure accuracy and internal consistency of reports and publications.
• Ensure that study results and conclusions are scientifically sound, clearly presented.
• Contribute to regulatory submissions and responses
• Mentor junior team members
• Provide statistical consultation to R&D labs, commercial lab and clinical development on use of 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 would be considered an added benefit.
• Minimum 5-8 years of experience working in Pharmaceutical, biotech or 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 desired.

Additional Details:

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes: 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 And more! Please refer to our page to view detailed benefits at https://caredx.com/company/careers

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team.

Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program.

This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

San Francisco Bay Area Roles $158,000 — $205,000 USD This is the anticipated base salary range in the United States. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

Remote: US only roles $150,000 — $195,000 USD