Be an early applicantLess than 25 applicants

Company

Natera · 9 hours ago

Staff Biostatistician

United States

Full-time

Remote

Senior Level, Lead/Staff

$156K/yr - $194K/yr

8+ years exp

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BiotechnologyGenetics

H1B Sponsor Likely

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Responsibilities

Lead Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.)

Lead interactions with regulatory authorities

Lead statistical calculations and analyses for studies of varying complexity

Promote statistical and regulatory best practices

Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation

Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders

Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams

Stay current with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissions

Mentor and provide technical supervision to junior team members

Perform other duties as assigned

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.

BiostatisticsIVD expertiseStatistical analysis softwareNext-generation sequencingRegulated environmentsStatistical methodologyRegulatory interactionsComplex biomarkersClinical study designCross-functional collaborationHigh-quality documentation

Required

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

At least 8 years of experience in Biostatistics, preferably within molecular diagnostics, biotechnology, or related fields.

Demonstrated experience in regulated environments.

Experience evaluating next-generation sequencing (NGS), genetic, and/or oncology-related data.

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

Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and FDA guidelines.

Previous experience interacting with regulatory bodies such as the FDA.

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.

Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences.

Attention to detail and a commitment to delivering high-quality work under tight deadlines.

Preferred

Prior experience with complex biomarkers (e.g., TMB, MSI, Methylation)

Experience in design of both non-clinical (analytical) and clinical studies

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

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)