Sr. Lead Biostatistician (Oncology Evidence Generation)

Location: Durham or Raleigh, North Carolina, United States. Monday–Friday, first shift; occasional travel of up to 10–15%.

Company

hirify.global provides laboratory services, diagnostics, data, and research solutions for healthcare providers, patients, pharmaceutical companies, and researchers.

What you will do

• Design and provide statistical leadership for oncology studies focused on minimal residual disease, clinical validity, registries, and real-world evidence.
• Define endpoints, analysis strategies, sample sizes, power calculations, and statistical sections of study protocols.
• Perform reproducible analyses across clinical, assay-validation, registry, and real-world datasets using regression, survival analysis, and validation methods.
• Act as the statistical point of contact for studies and communicate methods and results to clinical, scientific, data, operational, and external partners.
• Develop and manage statistical analysis plans, tables, listings, figures, study reports, templates, tools, and workflows.
• Contribute to abstracts, manuscripts, scientific presentations, publication strategy, and data-driven study-risk recommendations.

Requirements

• MS in Biostatistics, Statistics, or a related quantitative field.
• At least 6 years of clinical biostatistics experience in biotechnology, diagnostics, CRO, healthcare, or a related environment.
• At least 5 years of statistical programming experience with R, SAS, or an equivalent tool.
• At least 3 years supporting clinical research studies, including observational studies, registries, or assay-validation efforts.
• At least 3 years independently managing analyses and statistical deliverables across multiple concurrent studies.
• Strong clinical study design, applied statistical leadership, communication, collaboration, analytical, and organizational skills.

Nice to have

• PhD in Biostatistics, Statistics, or a related quantitative field.
• Experience in oncology, biomarker-driven studies, precision oncology, real-world data, registry research, or observational study designs.
• Experience with scientific publications, MRD, ctDNA, genomics/NGS-based assays, molecular diagnostics, protocols, SAPs, or GCP principles.

Culture & Benefits

• Cross-functional collaboration with clinical, translational, data, operational, academic, and external investigator partners.
• Comprehensive benefits for employees regularly scheduled to work 20 or more hours per week, including medical, dental, vision, life, short- and long-term disability coverage.
• 401(k), paid time off or flexible time off, tuition reimbursement, and employee stock purchase plan.
• Equal opportunity workplace focused on inclusion and belonging.