Biostatistician - De Novo / PMA - Job ID: 241894

Medix™; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Fractional Biostatistician to contribute to critical clinical and regulatory efforts. This exciting contract opportunity allows you to leverage your extensive experience in biostatistics and FDA submissions to design impactful clinical studies. Collaborate with dedicated teams to ensure compliance with rigorous standards while making a significant impact on the development of groundbreaking diagnostic solutions. If you have a strong background in in vitro diagnostics and are passionate about advancing healthcare, this role offers the flexibility and challenge you seek.

Qualifications

• 10+ years of experience in Biostatistics within the medical device industry.
• Expertise in FDA regulatory submissions, especially De Novo and PMA pathways.

Responsibilities

• Design clinical studies that meet FDA requirements for submissions.
• Execute final data analysis using SAS and ensure data integrity.

Skills

SAS Programming

Biostatistics

FDA Submissions

Clinical Trial Methodology

Data Integrity Principles

Education

Master's Degree in Statistics or Biostatistics

Tools

SAS

Job description

This range is provided by Medix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100.00/hr - $200.00/hr

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Contract Opportunity (Fractional)

The Opportunity:

We're seeking a highly experienced and motivated Fractional Biostatistician to play a crucial role in our clinical and regulatory efforts. This is an exciting contract opportunity for a seasoned professional with a strong background in in vitro diagnostics (IVD) and a proven track record of successful FDA submissions, particularly through the De Novo and PMA pathways.

As our Fractional Biostatistician, you will collaborate closely with our clinical and regulatory teams, providing expert statistical guidance to ensure our diagnostic studies meet the rigorous requirements of the FDA. This role offers the flexibility of contract work with the opportunity to make a significant impact on bringing innovative diagnostic solutions to market.

Key Responsibilities:

1. Collaborate with clinical and regulatory teams to design robust clinical studies that align with FDA requirements for De Novo and PMA submissions.
2. Lead the development and thorough documentation of the Statistical Analysis Plan (SAP), including clear and precise endpoint definitions and analytical methodologies.
3. Provide expert input on critical aspects of study design, including sample size estimation, appropriate population selection, and effective randomization strategies.
4. Advise on best practices for data collection and cleaning protocols to guarantee the integrity and readiness of data for analysis.
5. Independently execute final data analysis using SAS or equivalent statistical software.
6. Actively participate in interactions with the FDA, including pre-submission meetings and effectively addressing statistical queries.
7. Ensure strict adherence to relevant regulatory standards, including 21 CFR Part 11 and ISO 14155.

Type: Fractional / Contract

Estimated Duration: Approximately 100 hours over an estimated 3–6 month period.

Required Qualifications:

1. Master's Degree in Statistics, Biostatistics, or a closely related field.
2. A minimum of 10 years of progressive experience in Biostatistics within the medical device or diagnostic industry.
3. Demonstrable experience with FDA regulatory submissions for diagnostic devices, with significant experience in De Novo and/or PMA pathways being highly preferred.
4. Comprehensive understanding of in vitro diagnostics (IVD), with specific knowledge in infectious diseases (e.g., HIV, COVID-19) being advantageous.
5. Proven proficiency in SAS programming and the ability to independently manage necessary statistical software and tools for analysis.
6. Strong foundational knowledge of clinical trial methodology, advanced statistical modeling techniques, and data integrity principles.

Preferred Qualifications (Bonus Points For):

• Direct experience navigating the De Novo Pathway.
• Experience integrating data from Human Factors Studies or usability testing into statistical analyses.
• Prior experience working on at-home or self-testing diagnostic devices.
• Familiarity with the application of real-world evidence and post-market data analysis strategies in the diagnostic space.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Information Technology, Consulting, and Analyst

Industries

• Research Services and Biotechnology Research

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