Be an early applicantLess than 25 applicants

Company

Natera · 9 hours ago

Director of Biostatistics

United States

Full-time

Remote

Director/Executive

$182K/yr - $228K/yr

10+ years exp

Maximize your interview chances

BiotechnologyGenetics

H1B Sponsor Likely

Insider Connection @Natera

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Team Leadership: Build, mentor, and direct a high-performing biostatistics team, fostering collaboration, and overseeing their technical and professional development.

Study Design and Analysis: Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.

Cross-Functional Collaboration: Partner with bench scientists, regulatory, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.

Documentation and Reporting: Prepare high-quality protocols and reports for cross-functional internal and external collaborators and stakeholders.

Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA and the FDA.

Innovation and Improvement: Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

Strategic Leadership: Continuously improve the efficiency and efficacy of team through innovative techniques and strategies. Promote departmental standards for the development and execution of statistical analyses, ensuring alignment with company goals and regulatory requirements.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

BiostatisticsAnalytical ValidationStatistical MethodsNGSRegulatory ComplianceGeneticsOncology TestingDocumentation SkillsCross-Functional CollaborationMentoring

Required

Minimum 10 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries. At least 5 years leading a team.

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

Proven record of hiring, mentoring, and developing a successful, productive team

Expert working knowledge of statistical methods in diagnostic medicine (e.g., precision, accuracy, LoD/LoQ/LoB, linearity, etc.), including current CLSI and FDA guidelines

Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds

Strong track record of producing high quality written documentation for multiple audiences

Exceptional problem-solving skills and attention to detail

Preferred

Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus

Benefits

Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents

Free testing in addition to fertility care benefits

Pregnancy and baby bonding leave

401k benefits

Commuter benefits

Generous employee referral program

Company

Natera

Glassdoor

3.5

Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.

Founded in 2004

San Carlos, California, USA

1001-5000 employees

https://www.natera.com/

H1B Sponsorship

Natera has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (24)

2022 (54)

2021 (75)

2020 (47)