Biostatistician II

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

📋 Description

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

• Collaborate with clinical and scientific partners to establish study goals, endpoints, hypotheses, and statistical approaches.

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

• Analyze various datasets including clinical, observational, laboratory, and real-world data.

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

• Execute exploratory analyses on commercial and research data.

• Develop and validate statistical models aimed at assessing diagnostic performance, clinical outcomes, and other study endpoints.

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

• Conduct analyses involving longitudinal data, survival outcomes, missing data, confounding variables, subgroup analyses, and other intricate data structures.

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

• Assess datasets and analysis results for precision, completeness, consistency, and statistical integrity.

• Independently oversee assigned statistical analyses and deliverables.

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

• Contribute statistical content to study 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 for reproducible analyses.

• Record statistical methodologies, assumptions, analyses, and outcomes.

• Aid in enhancing statistical processes, standards, and analytical techniques.

• Report directly to the Director of Clinical Statistics & Data Management.

⛳️ Requirements

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

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

• Experience in the design and analysis of clinical, observational, or translational research studies.

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

• In-depth knowledge of regression analysis, categorical data analysis, longitudinal analysis, survival analysis, and techniques for managing missing data and confounding factors.

• Experience with analyzing highly multiplexed clinical assays.

• Proficient in statistical programming using R and/or SAS is essential.

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

• Strong grasp of data quality, analytical reproducibility, statistical validation, and documentation standards.

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

• Ability to manage statistical analyses independently while providing statistical guidance to cross-functional partners.

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

• Excellent written and verbal communication skills, capable of conveying complex statistical concepts to both technical and non-technical audiences.

• Ability to juggle multiple priorities and work collaboratively in a fast-paced, cross-functional environment.

• A PhD is preferred.

• Familiarity with diagnostic test performance measures is preferred.

• Experience with Python and SQL is preferred.

• Knowledge of regulatory requirements, Good Clinical Practice (GCP), and statistical practices in regulated life sciences settings is preferred.

• Proven ability to work independently while knowing when to seek guidance or escalate issues.

• Strong attention to detail and dedication to accuracy, quality, and scientific rigor.

• Exceptional organizational skills and the ability to manage multiple priorities and deliverables.

• A collaborative and proactive attitude towards working with cross-functional partners.

• Capability to navigate uncertainty and adjust as study or business priorities shift.

• Demonstrated accountability and ownership of assigned tasks.

• Commitment to continuous learning and enhancement of statistical and analytical practices.

🏝️ Benefits

• Full-time employment.

• Option for remote work within the USA or a hybrid arrangement in Redwood City.

• Travel opportunities for team events, up to 15%.

• Chance to work with genomics, AI, and cutting-edge diagnostic technologies.

• Equal employment opportunity and accommodations for qualified individuals with disabilities.