Position SummaryThe Biostatistician II supports the design, analyses and interpretation of clinical, observational, translational, and research studies with minimal guidance. This position owns defined statistical deliverables, develops statistical analysis plans, produces documentation for publication and regulatory submissions, and partners with cross-functional stakeholders to ensure analyses are scientifically rigorous, reproducible, and appropriately interpreted.
Reports to: Director, Clinical Statistics & Data Management
Location: Remote
Primary Responsibilities- Independently perform statistical analyses for clinical studies, research initiatives, product development activities, and evidence-generation efforts.
- Partner with clinical and scientific stakeholders to define study objectives, endpoints, hypotheses, and appropriate statistical methodologies.
- Develop statistical analysis plans, including sample size and power calculations, analysis populations, statistical methods, and sensitivity analyses.
- Analyze clinical, observational, laboratory, and real-world datasets using appropriate statistical techniques.
- Support the design and analysis of prospective and retrospective clinical studies.
- Support exploratory analysis of Karius' large archive of commercial and research data as needed.
- Develop and validate statistical models to evaluate diagnostic performance, clinical outcomes, and other study endpoints.
- Analyze diagnostic performance measures, including sensitivity, specificity, diagnostic value, agreement measures, and other relevant metrics.
- Perform analyses involving longitudinal data, survival outcomes, missing data, confounding, subgroup analyses, and other complex data structures, as appropriate.
- Collaborate with Data Science, Bioinformatics, Clinical Development, Medical Affairs, and Research and Development teams to ensure statistical rigor and appropriate interpretation of results.
- Review datasets and analysis outputs for accuracy, completeness, consistency, and statistical validity.
- Independently manage assigned statistical analyses and deliverables.
- Interpret analytical findings and communicate results clearly to technical and non-technical audiences.
- Contribute statistical content to study reports, abstracts, manuscripts, posters, presentations, regulatory materials, and other scientific communications.
- Support responses to statistical questions arising during scientific, clinical, regulatory, or publication review.
- Develop robust, reusable statistical programs, workflows, and documentation that support reproducible analyses.
- Maintain appropriate documentation of statistical methodologies, assumptions, analyses, and results.
- Contribute to continuous improvement of statistical processes, standards, and analytical approaches.
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 Requirements- Master's degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative field required; PhD preferred.
- 3-5 years of relevant biostatistics experience in biotechnology, diagnostics, pharmaceuticals, healthcare, academia, or a related life sciences environment.
- Experience designing and analyzing clinical, observational, or translational research studies.
- Experience developing statistical analysis plans, including study endpoints, sample size and power calculations, analysis populations, and statistical methodologies.
- Strong knowledge of statistical methods, including regression analysis, categorical data analysis, longitudinal analysis, survival analysis, and methods for addressing missing data and confounding.
- Proficiency with diagnostic test performance measures, including sensitivity, specificity, diagnostic value, and agreement measures, preferred.
- Experience analyzing highly multiplexed clinical assays.
- Proficiency within statistical programming using R and/or SAS required; experience with Python and SQL preferred.
- Experience working with complex clinical, biological, genomic, or real-world datasets.
- Strong understanding of data quality, analytical reproducibility, statistical validation, and documentation practices.
- Experience contributing statistical analyses to clinical study reports, abstracts, manuscripts, presentations, or regulatory submissions.
- Ability to independently manage statistical analyses and provide statistical guidance to cross-functional partners.
- Strong analytical, problem-solving, and critical-thinking skills.
- Excellent written and verbal communication skills, with the ability to communicate complex statistical concepts to both technical and non-technical audiences.
- Ability to manage multiple priorities and collaborate effectively in a fast-paced, cross-functional environment.
- Familiarity with regulatory requirements, Good Clinical Practice (GCP), and statistical practices within regulated life sciences environments preferred.
Personal Qualifications- Strong analytical, problem-solving, and critical-thinking skills.
- Demonstrated ability to work independently while recognizing when to seek input or escalate issues.
- Strong attention to detail with a commitment to accuracy, quality, and scientific rigor.
- Ability to evaluate analytical problems and recommend thoughtful, data-driven solutions.
- Strong organizational skills with the ability to manage multiple priorities and deliverables.
- Excellent written and verbal communication skills, including the ability to explain statistical concepts clearly to technical and non-technical audiences.
- Collaborative and proactive approach to working with cross-functional partners.
- Ability to navigate ambiguity and adapt effectively as study or business priorities evolve.
- Demonstrated accountability and ownership for assigned work.
- Commitment to continuous learning and improvement of statistical and analytical practices.
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.
$117,446 - $176,168 a year
