Advanced degree in Biostatistics, Statistics, or related quantitative field (Ph.D. preferred)
4+ years of experience in clinical trial biostatistics
Expertise in time-to-event analysis with advanced survival modeling approaches
Demonstrated experience with innovative study designs and power calculations
Familiarity with ICH and GCP guidelines plus CDISC standards
Proficiency in R programming language
Responsibilities
Lead statistical design and analytical planning for oncology clinical studies
Collaborate with clinical and medical teams to influence study planning and execution
Author and review statistical deliverables like analysis plans and reports
Recommend and apply novel statistical methods for study improvement
Mentor junior statisticians and enhance departmental processes
Benefits
Opportunity to work on cutting-edge oncology diagnostics
Collaborative cross-functional work environment
Chance to mentor early career professionals
Engagement in innovative statistical applications
Remote work flexibility
Full Job Description
This is an exciting opportunity for a Senior Biostatistician to support the adoption of Natera's oncology portfolio of innovative molecular diagnostic tests. You will contribute to the design, analysis, and reporting of oncology clinical trials while working closely with senior team members. You will assist in developing appropriate study designs and help generate insights that support the broader oncology portfolio.
The ideal candidate brings deep statistical expertise, strong scientific communication skills, and experience with applied statistics in a fast-paced, collaborative environment.
PRIMARY RESPONSIBILITIES:
Study Design and Statistical Strategy: Support the statistical design for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. With guidance, propose and justify efficient study designs tailored to complex oncology use cases.
Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution.
Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and knowledge. Collaborate on manuscripts for publications.
QUALIFICATIONS:
Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
0-2+ years of experience in clinical trial biostatistics.
Expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
Proficient in R.
KNOWLEDGE, SKILLS, AND ABILITIES:
Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.
Preferred qualifications:
Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
Experience with non-inferiority studies.
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$118,800-$148,500 USD
About Natera
Natera is a biotechnology company that focuses on genetic testing and diagnostics. The company's products are designed to help diagnose and treat genetic diseases, cancer, and other conditions. Natera's pipeline includes products for reproductive health, oncology, and organ transplantation. The company was founded in 2003 and is headquartered in San Carlos, California.
