Director, BiostatisticsRemote US

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.

CareDX is seeking an experienced and result-driven Director of Biostatistics to lead evidence generation and publication pipeline in kidney program and drive the newly initiated Real World Evidence (RWE) program leveraging our rich transplant data warehouse. This pivotal role provides strategic and technical leadership in a cross-functional team in the design and execution of statistical strategies, study designs, analyses, and publications for CareDx sponsored clinical studies, collaborations with key opinion leaders and RWE. The successful candidate will be instrumental in fostering a highly collaborative and productive cross-functional team, creating an innovative ecosystem, and enabling a high-performance publication pipeline. This role will report directly to the Senior Director, Biostatistics..

Responsibilities

Playing a critical role as a lead statistician for clinical program(s) and studies and the subject matter expert (SME) This position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle and drive technical and strategical leadership in RWE across indications

• Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timelines
• Provide statistical expertise and consultation on study design and interpretation of results
• Participate in the design, analysis and reporting of clinical trials or other scientific research studies
• Provide input for study documents including study protocols and clinical study reports, randomization specifications
• Collaborate with Clinical Data Management to provide input for case report form design, data review, and external data transfer specifications
• Collaboration with the study team to review data and meet data freeze and lock timelines
• Develop statistical analysis plans and manage the execution of the analysis in a timely manner.
• Perform and manage statistical ad hoc analysis.
• Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications. Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.
• Evaluate the potential development of novel statistical methodology.
• Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.
• Mentor junior team members.

Qualifications
Level will be based on education and years of experience.
Education:

• MS (with 10+ years of experience) or PhD (with 8+ experience) in Statistics, Biostatistics, or a highly related field required.

Additional Requirements

• High degree of technical competence. Able to perform statistical analyses and simulations in SAS or R.
• Effective communication skills, both oral and written
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
• Highly motivated to drive innovation
• Direct experience and deep domain knowledge with RWE.
• Pharmaceutical, biotech or related industry knowledge 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 athttps://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 and participates in the E-Verify program.

By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx.

***We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.***

Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy.