Staff Biostatistician

Redwood City, CA (Hybrid) or Remote (USA)Clinical & Medical – Clinical Affairs /Full-time /RemoteAbout KariusKarius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.Position SummaryThe Staff Biostatistician serves as a senior statistical expert and leads statistical strategy across multiple complex studies or interconnected programs. This position applies deep statistical expertise to complex and ambiguous scientific questions, influences study and analytical strategy, and establishes statistical approaches and best practices. The Staff Biostatistician works across functions to ensure statistical rigor and serves as a technical mentor to other statisticians and analytical partners.Why Should You Join Us?Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.Reports to: Director, Clinical Statistics & Data ManagementLocation: Redwood City (Hybrid) or Remote (USA), United StatesPrimary ResponsibilitiesLead statistical strategy across multiple clinical, diagnostic, translational, research, or evidence-generation studies and programs.Serve as a statistical expert to clinical, scientific, technical, product, and regulatory stakeholders.Lead statistical aspects of complex study design, including endpoint strategy, sample size determination, analysis populations, methodology selection, and sensitivity analyses.Develop statistical approaches for complex, novel, or ambiguous scientific and clinical questions.Apply advanced statistical methodologies to complex clinical, diagnostic, genomic, laboratory, and real-world datasets.Lead statistical evaluation of diagnostic performance, clinical outcomes, longitudinal data, survival outcomes, missing data, confounding, subgroup analyses, and other complex endpoints.Identify methodological risks, limitations, and opportunities and recommend statistically rigorous approaches.Provide statistical leadership in interpreting study findings and determining appropriate conclusions.Influence study design, evidence-generation strategy, and cross-functional decision-making through statistical expertise.Lead statistical content for study reports, regulatory materials, manuscripts, abstracts, presentations, and external scientific communications.Support statistical components of regulatory interactions and responses, as appropriate.Establish and improve statistical standards, reusable methodologies, workflows, and analytical best practices.Review complex statistical work and provide technical oversight and guidance to other statisticians.Mentor statisticians and analytical partners and support development of statistical capabilities across the team.Stay current with evolving statistical methodologies, regulatory expectations, and diagnostic research practices and incorporate relevant advances into organizational approaches.Demonstrated experience mentoring and providing technical guidance to statisticians and other analytical partners.Strong scientific judgment, communication, collaboration, and influencing skills.Strong knowledge of regulatory expectations and statistical practices within regulated life sciences environments preferred.What’s Fun About the Job?Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters. Travel: Travel required up to 15% for team events. Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.Position RequirementsMaster’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative field required; PhD preferred.7–10 years of relevant biostatistics experience in biotechnology, diagnostics, pharmaceuticals, healthcare, academia, or a related life sciences environment.Extensive experience designing and analyzing complex clinical, observational, translational, diagnostic, or evidence-generation studies.Extensive experience developing and leading statistical analysis plans, including study endpoints, sample size and power calculations, analysis populations, statistical methodologies, sensitivity analyses, and approaches to complex methodological challenges.Expert knowledge of statistical methods, including regression analysis, categorical data analysis, longitudinal analysis, survival analysis, repeated measures, missing data methodologies, confounding, subgroup analyses, and advanced statistical modeling approaches.Significant experience analyzing diagnostic test performance, including sensitivity, specificity, predictive values, agreement measures, and other relevant performance metrics, preferred.Knowledge of advanced methods for analyzing highly multiplexed clinical assays.Demonstrated experience with statistical programming using R and/or SAS required; experience with Python and SQL preferred.Extensive experience working with complex clinical, biological, genomic, laboratory, or real-world datasets.Deep understanding of data quality, analytical reproducibility, statistical validation, programming standards, and documentation practices.Demonstrated experience leading statistical contributions to clinical study reports, abstracts, manuscripts, presentations, regulatory submissions, or other high-impact scientific deliverables.Ability to lead statistical strategy across multiple studies or interconnected workstreams and provide expert statistical guidance to cross-functional teams.Ability to identify statistical risks, methodological limitations, and analytical opportunities and recommend appropriate approaches.Demonstrated ability to influence study design, analytical strategy, and cross-functional decision-making through statistical expertise.Strong analytical, problem-solving, and scientific judgment, with the ability to address novel or ambiguous statistical challenges.Excellent written and verbal communication skills, with the ability to translate complex statistical concepts into clear recommendations for diverse audiences.Demonstrated ability to manage multiple complex priorities and collaborate effectively across clinical, scientific, technical, product, and regulatory functions.Experience mentoring and providing technical guidance to statisticians and other analytical partners.Strong knowledge of regulatory requirements, Good Clinical Practice (GCP), and statistical practices within regulated life sciences environments preferred.Personal QualificationsExceptional analytical and problem-solving skills with strong scientific and statistical judgment.Ability to independently address highly complex, novel, or ambiguous problems and develop practical solutions.Demonstrated ability to think beyond individual analyses and consider broader study, program, and organizational implications.Strong strategic thinking with the ability to connect statistical decisions to clinical and scientific objectives.Demonstrated ability to influence decisions through expertise, evidence, and sound judgment.Excellent communication skills with the ability to make complex statistical concepts accessible and actionable for diverse audiences.Strong collaboration and relationship-building skills across disciplines and levels of the organization.Ability to identify risks, challenge assumptions constructively, and provide clear recommendations.Demonstrated ability to mentor and develop other technical contributors.High degree of ownership, initiative, and accountability.Commitment to advancing statistical rigor, analytical quality, and best practices across the organization.DisclaimerThe above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.