Staff Biostatistician

This is a fully remote position, open to applicants in California.

📋 Description

• Conduct statistical analyses independently for clinical trials, research projects, product development tasks, and evidence generation activities.

• Establish study goals, endpoints, hypotheses, and statistical approaches in collaboration with clinical and scientific partners.

• Create statistical analysis plans that outline sample size and power calculations, analysis populations, statistical techniques, and sensitivity analyses.

• Examine clinical, observational, laboratory, and real-world data sets.

• Assist in the design and analysis of both prospective and retrospective clinical studies.

• Investigate Karius’ commercial and research data archives.

• Develop and validate statistical models to assess diagnostic performance, clinical outcomes, and other study endpoints.

• Evaluate sensitivity, specificity, diagnostic value, agreement measures, and various diagnostic performance metrics.

• Conduct analyses involving longitudinal data, survival outcomes, handling of missing data, confounding variables, and subgroup analyses.

• Work collaboratively with teams in Data Science, Bioinformatics, Clinical Development, Medical Affairs, and Research and Development.

• Review datasets and analysis outputs to ensure they are accurate, complete, consistent, and statistically valid.

• Oversee assigned statistical analyses and their associated deliverables.

• Interpret results and communicate findings to both technical and non-technical audiences.

• Contribute statistical content for reports, abstracts, manuscripts, posters, presentations, regulatory documents, and scientific communications.

• Assist in addressing statistical inquiries during scientific, clinical, regulatory, or publication reviews.

• Develop reusable statistical programs, workflows, and documentation to ensure reproducibility of analyses.

• Maintain comprehensive documentation of methodologies, assumptions, analyses, and outcomes.

• Engage in the ongoing enhancement of statistical processes, standards, and analytical methodologies.

⛳️ Requirements

• A Master’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative discipline is required; a PhD is preferred.

• 3–5 years of pertinent biostatistics experience in biotechnology, diagnostics, pharmaceuticals, healthcare, academia, or a similar life sciences setting.

• Experience in designing and analyzing clinical, observational, or translational research studies.

• Proficiency in developing statistical analysis plans, including study endpoints, sample size and power calculations, analysis populations, and statistical methodologies.

• Strong expertise in regression analysis, categorical data analysis, longitudinal analysis, survival analysis, handling missing data, and addressing confounding factors.

• Experience with the analysis of highly multiplexed clinical assays.

• Required proficiency in statistical programming with R and/or SAS.

• Experience working with complex clinical, biological, genomic, or real-world datasets.

• Solid understanding of data quality, analytical reproducibility, statistical validation, and documentation practices.

• Experience in contributing statistical analyses to clinical study reports, abstracts, manuscripts, presentations, or regulatory submissions.

• Ability to independently manage statistical analyses and offer statistical guidance to cross-functional teams.

• Familiarity with regulatory requirements, Good Clinical Practice (GCP), and statistical practices in regulated life sciences environments is preferred.

• Strong analytical, problem-solving, and critical-thinking abilities.

• Excellent written and verbal communication skills.

• Capability to manage multiple priorities and collaborate effectively in a fast-paced, cross-functional setting.

🏝️ Benefits

• Travel may be required up to 15% for team events.

• Equal employment opportunities.

• Accommodations available for qualified individuals with disabilities.