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Staff Clinical Biostatistician
3 months ago
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 a highly motivated, experienced and skilled statistician with experience in the diagnostics industry to fill the role of 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 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 Medical Affairs, Clinical Operations, Laboratory Operations, Technical Operations, and Manufacturing/Process Development.
Responsibilities:
- Provide statistical expertise and guidance to all clinical studies and publications conducted by CareDx or research collaborators.
- Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timelines.
- Co-author study protocol and amendments.
- Contribute to the clinical study design in the context of product development and support the performance claim.
- Develop statistical analysis plans. Provide programming specifications for derived variables and analysis datasets. Independently perform statistical analyses as per the analysis plan.
- Perform sample size calculations.
- Perform statistical ad hoc analysis.
- Identify and report data issues or violations of study assumptions.
- Collaborate with Statistical Programming to ensure the delivery of high-quality outputs in a timely manner.
- Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.
- Contribute to regulatory submissions and responses.
- Mentor junior team members.
- Consult with research and development labs, commercial lab and clinical development on use of proper experimental design methods and statistical techniques.
- Manage personnel, allocate resources to cross functional initiatives.
- Other duties as assigned
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 with gene expression, proteomic, genetic or other genomic data sets desired
- 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 includes:
Competitive base salary and incentive compensationHealth and welfare benefits including a gym reimbursement program401(k) savings plan matchEmployee Stock Purchase PlanPre-tax commuter benefitsAnd moreIn 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.
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