Description
Staff Biostatistician
Location: San Diego, CA
Department: General
About TruvianTruvian is a fast-paced and disruptive healthcare company at the intersection of diagnostics and consumer technology. We are developing a fully automated benchtop system that delivers lab-accurate results from a small blood sample under 30 minutes—designed for use in retail clinics or private practice settings.
Our proprietary platform, currently under FDA review, is built to make routine blood testing more accessible, affordable, and actionable. At Truvian, we’re not just building a product—we’re building a movement to empower people with better health data, on demand.
We are a team of trailblazers committed to discovery, collaboration, and innovation. If you’re looking for meaningful work in a mission-driven environment, join us on our journey to transform healthcare.
Position Summary
Truvian is seeking a Staff Biostatistician to provide strategic and technical leadership in biostatistics for analytical and clinical study design, execution, and analysis. This is a hands-on role where you will lead statistical strategy while also performing analyses that contribute directly to regulatory filings, publications, and internal data reviews.
You will work cross-functionally with teams in product development, regulatory affairs, scientific affairs, and marketing, playing a pivotal role in validating Truvian’s blood testing technology for market readiness.
Here’s Why You’ll Love This Job
- Lead statistical strategy for a breakthrough technology in diagnostic healthcare.
- Contribute to a high-impact product launch and shape the future of patient-centered diagnostics.
- Collaborate with passionate, mission-driven professionals in a fast-paced, agile work environment.
- Enjoy perks including:
- Medical, dental, and vision coverage
- 401(k) plan
- Paid parental leave and flexible PTO
- Craft coffee, cold brew, and kombucha on tap
- Healthy snacks and a farm-to-table restaurant with an employee discount
- On-site gym and virtual wellness classes
What You’ll Do
- Provide statistical leadership for analytical and clinical studies across the product lifecycle.
- Design protocols and statistical analysis plans; conduct analyses supporting regulatory submissions, validations, and publications.
- Lead clinical trial statistical components, including sample size calculations and endpoint analyses (e.g., sensitivity, specificity, PPV, NPV).
- Perform data quality control and ensure consistency, accuracy, and regulatory compliance.
- Prepare study reports, regulatory documentation, and scientific presentations.
- Integrate data from multiple sources to drive evidence-based decision-making.
- Support analytical verification and clinical validation efforts per CLSI guidelines.
- Participate in regulatory discussions and contribute statistical insights to internal teams.
What You’ll Bring
- Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of industry experience, OR M.S. with 8+ years, OR B.S. with 12+ years in biostatistics within the IVD or Biotech space.
- Proven experience designing and analyzing clinical and analytical studies for IVDs.
- Strong working knowledge of regulatory frameworks and design control processes.
- Proficiency with statistical software (e.g., R, Python, SAS, JMP, SPSS, Alteryx, Analyse-It).
- Deep understanding of clinical accuracy metrics and statistical methods for diagnostics.
- Strong written and verbal communication skills to clearly explain statistical insights.
- Ability to work independently in a startup environment and manage competing priorities.
- Experience with cloud platforms (e.g., AWS or Azure) is a plus.
Supervisory Responsibilities
This is an individual contributor role with no direct reports.
Physical Demands
- Ability to lift and move up to 5 lbs. regularly
- Sitting and standing for long periods of time
- Visual requirements include close vision, color vision, and depth perception.
Salary Range
- $164,000 – $200,000
Equal Opportunity Employer
Truvian is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. We welcome all qualified applicants regardless of race, color, religion, sex, gender identity, national origin, disability, age, or veteran status.
Cover letters are strongly encouraged.
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