Lead Biostatistician

Natera, Inc.; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading biotechnology firm is seeking a clinical biostatistician to lead the design and analysis of oncology studies. The ideal candidate will have a Ph.D. or Master's degree in Biostatistics or Statistics and at least 5 years of experience in clinical biostatistics. You will collaborate with cross-functional teams and contribute to the documentation and reporting of studies. This role offers an opportunity to apply advanced statistical methods in a fast-paced environment.

Qualifications

• 5+ years of relevant clinical biostatistics experience in oncology or diagnostics.
• 4+ years of experience with statistical analysis software.
• Experience in complex clinical study designs and statistical methods.

Responsibilities

• Provide technical leadership in oncology clinical studies.
• Act as the statistical representative on project teams.
• Contribute to protocols, statistical analysis plans, and reports.

Skills

Probability theory

Statistical analysis software (R, SAS)

Clinical trial design

Advanced statistical methods

Education

Ph.D. or Master's degree in Biostatistics, Statistics

Tools

R

SAS

Job description

This is an exciting opportunity for a clinical biostatistician to play a key role in the design and analysis of oncology studies within Natera’s ctDNA diagnostic portfolio. As a Lead Biostatistician, you will drive the design, analysis, and reporting across multiple oncology clinical trials.

PRIMARY RESPONSIBILITIES:

Study Design & Analysis: Provide technical leadership in the design, execution, and analysis of oncology clinical utility studies, including endpoint selection, sample size estimation, and methods strategy. Execute statistical analyses according to plans and protocols, as well as exploratory or ad-hoc investigations.

Cross-Functional Collaboration: Act as the statistical representative on project teams. Partner with clinical, translational, and medical teams to align study designs with clinical research objectives. Effectively convey statistical concepts and results to collaborators and stakeholders.

Documentation & Reporting: Contribute to protocols, statistical analysis plans (SAPs), tables/figures/listings (TFLs), and study reports. Ensure documentation meets internal standards and regulatory expectations.

Innovation & Improvement: Apply emerging or advanced statistical methods where appropriate. Contribute to the improvement of internal tools, templates, and statistical best practices.

QUALIFICATIONS:

Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.

Minimum 5 years relevant clinical biostatistics experience, preferably in oncology, diagnostics, or related biotech/pharma fields.

Minimum 4 years practical experience with statistical analysis software such as R (preferred) or SAS.

KNOWLEDGE, SKILLS, AND ABILITIES:

Expert knowledge of probability theory and statistics including the ability to produce novel methods based on first principles understanding

Solid foundation in clinical trial design approaches, regulatory expectations, and industry-aligned best practices

Experience with complex clinical study designs, sample size determination, and advanced analytical methods, including non-inferiority and adaptive trial designs

Familiarity with incorporating biomarker endpoints into trial design

Demonstrated proficiency and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds

Proven ability to independently develop high-quality, audience-tailored documentation that clearly communicates complex scientific and statistical concepts

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.