Associate Director – Computational Test Development

Precede Biosciences

Lead computational scientist for epigenomics-based liquid biopsy platform development. Collaborate with cross-functional teams to meet FDA regulatory standards.

Posted 5/29/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $180,000 - $245,000 per yearWebsite

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Design and develop computational approaches for characterizing the performance of existing and new epigenomic tests.
Define and implement metrics and analyses to assess NGS and epigenomic data quality to enable coordinated optimization of assay and diagnostic performance.
Lead the computational execution of verification and validation protocols, statistical analysis plans (SAPs), and performance summary reports to meet FDA evidentiary standards.
Translate complex computational results into clear, well-organized regulatory documentation for FDA submissions.
Stay current on FDA guidance for IVDs, companion diagnostics, and evolving LDT oversight to actively inform study design decisions.
Develop and apply statistical methods for diagnostic characterization, including LOD/LOQ, reproducibility, thresholding, gaurdbanding, and clinical utility endpoints.
Support and optimize robust, reproducible analysis pipelines—ensuring code traceability and standardization from raw NGS data through regulatory-grade outputs.
Identify and systematically address sources of variability, bias, and technical confounding across the computational workflow.
Partner closely with laboratory development, clinical operations, and regulatory affairs to ensure absolute scientific and regulatory alignment across programs.
Contribute to clinical study design—including sample size calculations, endpoint selection, and pre-specified SAPs using data-driven insights from analytical validation pilots.

Requirements

What you’ll need

PhD in computational biology, bioinformatics, biostatistics, or a closely related quantitative field. Direct experience with advanced NGS modalities (e.g., cell-free DNA, ChIP-Seq, or epigenomic signal processing) is highly preferred.
4–9 years of industry experience in regulated diagnostics, liquid biopsy, or IVD development, ideally within a fast-paced, cross-functional R&D environment.
Proven track record working under a formal Quality Management System (ISO 13485, 21 CFR Part 820).
Hands-on experience contributing to regulatory submissions (such as Pre-Subs, De Novo, or 510(k) tracks). Please describe your specific role and submission type in your cover letter or CV.
Solid grasp of analytical validation frameworks, including CLSI EP guidelines, FDA IVD/CDx guidance, and CAP/CLIA requirements.
Fluency in R and/or Python for robust statistical modeling, data analysis, and reproducible reporting.
Startup mindset: You thrive when taking autonomous ownership of projects, remain adaptive under evolving information, and execute effectively in an entrepreneurial environment.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Precede Biosciences Website LinkedIn All Job Openings 11 - 50 employees We've experienced the significant gaps in our collective ability, as a medical and research community, to access and understand disease-defining biology when it matters most. To address this, we've developed a simple blood test to uncover actionable disease-defining transcriptional biology. Our unique genome-wide platform profiles circulating chromatin and the DNA methylome to deliver resolution into the dynamic activity of individual genes and pathways in diseased tissues from just 1mL of plasma. By partnering with developers of new medicines and advancing our own diagnostic tests, we’re working towards a world where new medicine development efforts succeed more frequently, and where anyone can receive a minimally invasive diagnosis and treatment that’s precise to the biology of their disease. Associate Director – Computational Test Development 🔥 31 minutes ago 🏢🏡 Boston – Hybrid 💵 $180k - $245k / year ⏰ Full Time 🟠 Senior 🔧 QA Engineer (Quality Assurance) Python Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Design and develop computational approaches for characterizing the performance of existing and new epigenomic tests.
Define and implement metrics and analyses to assess NGS and epigenomic data quality to enable coordinated optimization of assay and diagnostic performance.
Lead the computational execution of verification and validation protocols, statistical analysis plans (SAPs), and performance summary reports to meet FDA evidentiary standards.
Translate complex computational results into clear, well-organized regulatory documentation for FDA submissions.
Stay current on FDA guidance for IVDs, companion diagnostics, and evolving LDT oversight to actively inform study design decisions.
Develop and apply statistical methods for diagnostic characterization, including LOD/LOQ, reproducibility, thresholding, gaurdbanding, and clinical utility endpoints.
Support and optimize robust, reproducible analysis pipelines—ensuring code traceability and standardization from raw NGS data through regulatory-grade outputs.
Identify and systematically address sources of variability, bias, and technical confounding across the computational workflow.
Partner closely with laboratory development, clinical operations, and regulatory affairs to ensure absolute scientific and regulatory alignment across programs.
Contribute to clinical study design—including sample size calculations, endpoint selection, and pre-specified SAPs using data-driven insights from analytical validation pilots. 🎯 Requirements
PhD in computational biology, bioinformatics, biostatistics, or a closely related quantitative field. Direct experience with advanced NGS modalities (e.g., cell-free DNA, ChIP-Seq, or epigenomic signal processing) is highly preferred.
4–9 years of industry experience in regulated diagnostics, liquid biopsy, or IVD development, ideally within a fast-paced, cross-functional R&D environment.
Proven track record working under a formal Quality Management System (ISO 13485, 21 CFR Part 820).
Hands-on experience contributing to regulatory submissions (such as Pre-Subs, De Novo, or 510(k) tracks). Please describe your specific role and submission type in your cover letter or CV.
Solid grasp of analytical validation frameworks, including CLSI EP guidelines, FDA IVD/CDx guidance, and CAP/CLIA requirements.
Fluency in R and/or Python for robust statistical modeling, data analysis, and reproducible reporting.
Startup mindset: You thrive when taking autonomous ownership of projects, remain adaptive under evolving information, and execute effectively in an entrepreneurial environment. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Quality Engineer, QMS 🕒 Yesterday Beacon Biosignals 11 - 50 🧬 Biotechnology ⚕️ Healthcare Insurance 🔬 Science Website LinkedIn All Job Openings Quality Engineer maintaining and improving compliance of the Quality Management System at Beacon Biosignals. Supporting quality management in the regulated medical device industry with hands-on problem solving. 🏢🏡 Boston – Hybrid ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) Senior Software Quality Engineer 🕒 April 17 Red Hat 10,000+ employees 🏢 Enterprise Website LinkedIn All Job Openings Senior Software Quality Engineer implementing automated test strategies for quality software at Red Hat. Collaborating with teams and exploring innovative testing approaches for RHEL AI software. 🏢🏡 Boston – Hybrid 💵 $178.1k - $198.6k / year 💰 Corporate Round on 1999-03 ⏰ Full Time 🟠 Senior 🔧 QA Engineer (Quality Assurance) 🦅 H1B Visa Sponsor Python Senior Specialist, Quality Assurance Operations 🕒 January 9 enGene 11 - 50 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Senior Specialist QA Operations overseeing quality at CDMO partners while ensuring compliance with GMP standards. Collaborating with CMC, Quality Control, and Regulatory teams for project advancement. 🏢🏡 Boston – Hybrid 💵 $115k - $135k / year ⏰ Full Time 🟠 Senior 🔧 QA Engineer (Quality Assurance) Quality Assurance Engineer - Manufacturing 🕒 July 5, 2025 Xometry 1001 - 5000 Website LinkedIn All Job Openings Join Xometry as a Quality Assurance Engineer, enhancing supplier quality and compliance for manufacturing processes. 🏢🏡 Boston – Hybrid 💰 $75M Series E on 2020-09 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔧 QA Engineer (Quality Assurance) 🦅 H1B Visa Sponsor Tableau View More QA Engineer Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

computational biologybioinformaticsbiostatisticsnext-generation sequencing (NGS)statistical analysisanalytical validationstatistical modelingdata analysisregulatory documentationquality management system

Soft Skills

project ownershipadaptabilityentrepreneurial mindsetcollaborationcommunication