Biostatistician

ABOUT
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 30 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.

To us, our work at Truvian is more than a job – It’s a mission.  We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!

JOB SUMMARY
Truvian is seeking a Biostatistician as we enter the next phase of our evolution.  This position is ONSITE.  In this role, you will provide biostatistics in support of analytical and clinical studies.
We are seeking a collaborative, detail-oriented, and eager-to-learn Biostatistician with at least 2 years of experience, ideally with exposure to In Vitro Diagnostic (IVD) devices, assay development, or healthcare data. This role is a great fit for someone who is passionate about building their statistical expertise while contributing to clinical research, analytical studies, and regulatory submissions for innovative diagnostic products. You will work closely with cross-functional teams to support study design, data analysis, and reporting, helping to ensure that data generated for IVD assays meets regulatory standards and supports product performance claims—all within a fast-paced, growth-focused start-up environment.

If you want to deepen your knowledge of clinical studies, data analysis, FDA submissions, and regulatory strategy—all while working alongside experienced mentors—this role is for you. This role will report to the Director, Biostatics.

HERE’S WHY YOU’LL LOVE THIS JOB:

• Unique Growth Opportunity: Gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development.
• Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.
• Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.
• Professional Development: Receive mentorship and opportunities to expand your technical and industry knowledge.
• Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.
• You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
• You’ll have great perks such as:
  • Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
  • Flexible vacation
  • Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
  • Onsite gym and virtual classes
  • Farm to table onsite restaurant including a 30% discount

WHAT YOU WILL DO:
Broadly, this role is supporting the delivery of Truvian’s diagnostic products into diverse, global end markets. You will:

• Take initiative in supporting the design, statistical analysis, and interpretation of data for studies related to IVD product development, assay validation, and clinical research.
• Apply and grow your statistical expertise by analyzing complex datasets, performing data cleaning, summarizing results, and generating clear, data-driven insights that support product claims.
• Collaborate with senior biostatisticians and cross-functional teams to develop and implement statistical analysis plans, ensuring data is robust, accurate, and aligned with regulatory requirements.
• Proactively identify opportunities to improve data quality, analysis approaches, and reporting processes.
• Participate in the preparation of reports, presentations, and documents for internal teams, clinical studies, and FDA regulatory submissions, including Q-Subs and other filings.
• Demonstrate curiosity and hunger to learn new statistical methods, data analysis techniques, and regulatory expectations.
• Engage in cross-functional problem-solving, using a data-driven approach to support decisions across Clinical, Regulatory, R&D, and Quality teams.
• Take ownership of expanding your technical toolkit by learning new software, coding practices, and analytical approaches that enhance the integrity and impact of study results.
• Stay current with evolving statistical methodologies, regulatory expectations, and industry standards related to IVD assays and diagnostics to ensure compliance and maintain scientific excellence.

WHAT YOU WILL BRING:
The ideal candidate will have:

• Bachelor’s degree in Biostatistics, Statistics, Mathematics, Data Science, or a related quantitative field required; Master’s degree (M.S.) preferred. 
• Minimum 2 years of experience in biostatistics, data analysis, or a related role (industry, academic research, or internships considered).
• Solid foundation in statistical principles with strong interest in applying data analysis to real-world healthcare problems. 
• Hands-on experience with statistical software such as R, SAS, Python, or similar tools.
• Analytical mindset with strong attention to detail and the ability to draw meaningful insights from complex datasets.
• Proactive, self-motivated, and eager to take ownership of tasks and learning opportunities.
• Excellent communication skills and ability to clearly explain statistical concepts to technical and non-technical audiences.
• Excited to learn and grow in the areas of clinical research, regulatory submissions, FDA processes, and IVD product development.
• Comfortable working in a fast-paced, start-up environment with shifting priorities.

PREFERRED (Not Required, But a Plus): 

• Exposure to In Vitro Diagnostic (IVD) product development, diagnostics, or medical devices.
• Familiarity with FDA regulatory processes, including Q-Submissions, 510(k), De Novo, or PMA pathways.
• Awareness of relevant regulatory standards such as CLSI guidelines, ISO 13485, or FDA guidance documents.
• Experience working with clinical data, assay validation studies, or large, complex datasets.

SUPERVISORY ROLE 

• No

SALARY RANGE
$116,000 – $140,000
This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to, experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.  Salary offers are determined based on final candidate qualifications and experience.  Placement within the compensation range is determined by internal equity and relevant qualifications.

PHYSICAL DEMANDS AND ABILITIES 

• Ability to lift and move over 5 lbs. repeatedly and safely
• Occasionally required to sit and climb or balance
• Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus

Interested candidates are encouraged to submit a cover letter along with their resume. The cover letter is an excellent opportunity to share how your experience aligns with our mission, your approach to collaboration, and how your statistical expertise can support innovation in IVD assay development.

Truvian  provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.