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Staff Biostatistician (Clinical Validation)

Work from home

Remote role where the employee must remain based in a particular country.

Listed for United States

Source: the job board's country tag. The advert itself does not name United States.

Employer listed it 13 days ago · Added 10 days ago

First listed 13 days ago and still open.

Salary

$164,000 to $205,000

Location

Listed for United States

Timezone

Not stated

Contract

Full-time

Experience

Lead

Category

Data

Stated by the employer in the job description

What the advert says

Quoted word for word from the employer's advert. Where it says nothing, we say so.

Working hours
Not mentioned in the advert
Where you can work from
Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
Contract
Not mentioned in the advert
Experience asked for
Not mentioned in the advert
Pay
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.

Remote flexibility

Work from home

This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.

What the employer says

  • Source listing states candidate location: "US Remote, US"
  • Job description states: "based in California"

What Nomaders makes of it

  • Payroll and tax are likely handled in that country only

The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.

Before you apply

Experience: employer states

Written as a requirement

  • “At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields.”
  • “Minimum of 4 years practical experience with R statistical analysis software”

Written as a nice-to-have

  • “Prior experience with germline assay development preferred”

Questions worth asking: Nomaders interpretation

  • The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.

Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.

About the role

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects.

PRIMARY RESPONSIBILITIES:

Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)

Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities.

Documentation and Reporting : Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders.

Cross-Functional Leadership : Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams

Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio

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

Mentor and provide technical supervision to junior team members

QUALIFICATIONS:

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

Experience :

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

Demonstrated experience in regulated environments, including previous CDx or IVD submission experience

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

Minimum of 4 years practical experience with R statistical analysis software

KNOWLEDGE, SKILLS, AND ABILITIES:

Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of 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

Prior experience with germline assay development preferred

Prior experience with kidney disease desired

Experience in design and analyses of clinical validation studies

Requirements

  • ·Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
  • ·At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields.
  • ·Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
  • ·Experience with next-generation sequencing (NGS), genetic, and/or germline-related data.
  • ·Minimum of 4 years practical experience with R statistical analysis software

Benefits

  • ·For more information, visit www.natera.com .
  • ·If you are based in California, we encourage you to read this important information for California residents.
  • ·Link: https://www.natera.com/notice-of-data-collection-california-residents/
  • ·For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

How to apply

  1. 1Check the flexibility label above, work from home, matches where you plan to live and work.
  2. 2Tailor your CV to the role at Natera, mentioning your remote working experience.
  3. 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.

Found 11d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.

Listing sourced from Company boards.

$164,000 to $205,000 · You'll be taken to the employer's careers page.