Lead Biostatistician (IVD Clinical)

How to use this kit

Ground every answer in facts on this page and the original listing. We never invent Glassdoor-style reviews or salaries that are not in our data.

Occupation tasks (O*NET)

Public-domain labor data — prepare examples for 2–3 of these.

• Draw conclusions or make predictions, based on data summaries or statistical analyses.
• Analyze clinical or survey data, using statistical approaches such as longitudinal analysis, mixed-effect modeling, logistic regression analyses, and model-building techniques.
• Write detailed analysis plans and descriptions of analyses and findings for research protocols or reports.
• Calculate sample size requirements for clinical studies.
• Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.
• Design research studies in collaboration with physicians, life scientists, or other professionals.
• Prepare tables and graphs to present clinical data or results.
• Write program code to analyze data with statistical analysis software.

O*NET source

Company facts (cached)

Website: natera.com

Natera, Inc. is a clinical genetic testing company based in Austin, Texas that specializes in non-invasive, cell-free DNA (cfDNA) testing technology, with a focus on women's health, cancer, and organ health. Natera's proprietary technology combines novel molecular biology techniques with a suite of bioinformatics software that allows detection down to a single molecule in a tube of blood. Natera operates CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, California and Austin, Texas.

Public cache only — not an employee review.

Role overview (listing rewrite)

Natera is seeking an experienced Lead Biostatistician specializing in in vitro diagnostic (IVD) clinical development for a full-time position in the United States. As a senior statistical leader, you will direct statistical strategy and execution for clinical studies supporting regulatory submissions across our oncology diagnostic portfolio. What This Role Involves You will serve as the principal statistical strategist on cross-functional clinical development teams, overseeing how data is collected, analyzed, and presented to regulatory agencies and clinical collaborators. Your responsibility is translating complex statistical concepts into clear, actionable insights for colleagues across research, clinical operations, and regulatory functions. This role combines deep technical mastery with hands-on leadership of the biostatistics team. What You'll Do Architect statistical methods supporting study protocols and analysis plans Direct execution of confirmatory, exploratory, and post-hoc statistical analyses according to protocol specifications Author regulatory-quality documentation of analysis approaches, results, and clinical interpretation Present statistical findings and methods to internal teams, external partners, and regulatory reviewers Identify analytical challenges and champion solutions across cross-functional project teams Mentor and supervise biostatistics staff members Support additional responsibilities as business needs evolve Who We're Looking For Master's degree in biostatistics or statistics with 5+ years in regulated clinical or diagnostic environments, or PhD in biostatistics or statistics with 3+ years of comparable experience Minimum 3 years designing and executing statistical analyses for regulated clinical trials and regulatory submissions At least 4 years of hands-on experience with statistical computing platforms (R strongly preferred; SAS or JMP also acceptable) Prior practical experience in diagnostic development or clinical laboratory testing Expert knowledge of probability theory and advanced statistical methods; ability to develop or adapt novel approaches Solid understanding of clinical trial design, regulatory standards, and FDA guidance for diagnostic product submissions Demonstrated ability to collaborate effectively with teams spanning diverse scientific and business disciplines Strong written and verbal communication skills, with a proven track record of producing clear, well-organized documentation for varied audiences Background in next-generation sequencing, genetics, or oncology diagnostics (valued, not required) Prior direct engagement with regulatory agencies such as the FDA (valued, not required) More About Natera Natera is the leading…

Full job on Get A Job.AI

Questions to ask them

• What does success look like in the first 90 days for this role?
• How is the team structured, and who would I work with most?
• What tools and systems does this role use daily?
• Is the work primarily based in United States, hybrid, or fully remote?