Sr. Staff Biostatistician

Role Description

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.

• 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.

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 allowing up to 30 days of paid leave annually for organ or bone marrow donation.
• And more!