Staff Biostatistician

The 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.

Position Summary

The Staff Biostatistician works across functions to ensure statistical rigor and serves as a technical mentor to other statisticians and analytical partners.

Primary Responsibilities

• Lead 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.

Requirements

• A Master’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative field is 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 Qualifications

• Exceptional 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.