FULL_TIME

FEED

YEAR

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. 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.

About Truvian Truvian 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<ul><li>Lead statistical strategy for a breakthrough technology in diagnostic healthcare.</li><li>Contribute to a high-impact product launch and shape the future of patient-centered diagnostics.</li><li>Collaborate with passionate, mission-driven professionals in a fast-paced, agile work environment.</li><li>Enjoy perks including:<ul style="list-style-type:circle"><li>Medical, dental, and vision coverage</li><li>401(k) plan</li><li>Paid parental leave and flexible PTO</li><li>Craft coffee, cold brew, and kombucha on tap</li><li>Healthy snacks and a farm-to-table restaurant with an employee discount</li><li>On-site gym and virtual wellness classes</li></ul></li></ul> What You’ll Do<ul><li>Provide statistical leadership for analytical and clinical studies across the product lifecycle.</li><li>Design protocols and statistical analysis plans; conduct analyses supporting regulatory submissions, validations, and publications.</li><li>Lead clinical trial statistical components, including sample size calculations and endpoint analyses (e.g., sensitivity, specificity, PPV, NPV).</li><li>Perform data quality control and ensure consistency, accuracy, and regulatory compliance.</li><li>Prepare study reports, regulatory documentation, and scientific presentations.</li><li>Integrate data from multiple sources to drive evidence-based decision-making.</li><li>Support analytical verification and clinical validation efforts per CLSI guidelines.</li><li>Participate in regulatory discussions and contribute statistical insights to internal teams.</li></ul> What You’ll Bring<ul><li>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.</li><li>Proven experience designing and analyzing clinical and analytical studies for IVDs.</li><li>Strong working knowledge of regulatory frameworks and design control processes.</li><li>Proficiency with statistical software (e.g., R, Python, SAS, JMP, SPSS, Alteryx, Analyse-It).</li><li>Deep understanding of clinical accuracy metrics and statistical methods for diagnostics.</li><li>Strong written and verbal communication skills to clearly explain statistical insights.</li><li>Ability to work independently in a startup environment and manage competing priorities.</li><li>Experience with cloud platforms (e.g., AWS or Azure) is a plus.</li></ul> Supervisory Responsibilities This is an individual contributor role with no direct reports. Physical Demands<ul><li>Ability to lift and move up to 5 lbs. regularly  </li><li>Sitting and standing for long periods of time</li><li>Visual requirements include close vision, color vision, and depth perception.</li></ul> Salary Range<ul><li style="margin-bottom:11px;margin-left:8px">$164,000 – $200,000</li></ul>The salary range reflects a wide set of factors, including experience, education, skills, certifications, and organizational needs. Final compensation will be determined based on qualifications and internal equity. 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.  Powered by JazzHR

Truvian Sciences

Staff Biostatistician

Amazon Web Services (AWS)

Analysis Skills

Biostatistics

Biotech and Pharmaceutical

Clinical Assessment

Clinical Trial

Clinical Validation

Cloud Computing

Communication Skills

Compensation Management

Cross-Functional

Data Quality

Depth Perception

FDA (Food and Drug Administration)

Healthcare

IBM SPSS Statistical Package

Leadership

Marketing

Medical Diagnosis

Metrics

Microsoft Windows Azure

Net Present Value (NPV)

Presentation/Verbal Skills

Product Development

Product Lifecycle

Product/Service Launch

Protocol Design

Publications

Python Programming/Scripting Language

Quality Control

R Programming Language

Regulations

Regulatory Compliance

Regulatory Reports

Regulatory Submissions

Reporting Skills

Restaurant

Retail

Scientific Publications

Startup

Statistical Analysis System (SAS)

Statistics

Statistics Software

Technical Leadership

Technical Strategy

Validation Testing

Writing Skills

partner JazzHR

The Director will architect and scale Truvian’s clinical data ecosystem — spanning database design, data pipeline integration, clinical data quality, statistical analysis, and data visualization — to support assay validation, regulatory submissions, and real-world evidence generation. Truvian is seeking a strategic and technically adept Director, Clinical Data Management & Data Science build and lead a multidisciplinary team responsible for clinical data strategy, management, analytics, and statistical sciences.

ABOUT TRUVIAN 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 strategic and technically adept Director, Clinical Data Management & Data Science build and lead a multidisciplinary team responsible for clinical data strategy, management, analytics, and statistical sciences. This role is pivotal in ensuring data integrity, regulatory compliance, and operational efficiency across the product lifecycle—from early research through regulatory submission and post-market surveillance.  This position is ONSITE. The Director will architect and scale Truvian’s clinical data ecosystem — spanning database design, data pipeline integration, clinical data quality, statistical analysis, and data visualization — to support assay validation, regulatory submissions, and real-world evidence generation. The ideal candidate combines strategic leadership with hands-on technical expertise in biostatistics, clinical data systems, and data science for diagnostics. This role requires in-depth expertise in the IVD industry, including knowledge of FDA regulations (21 CFR Part 11, Part 820), and a proven ability to lead data initiatives in a regulated environment. HERE’S WHY YOU WILL LOVE THIS ROLE<ul><li style="margin-left:8px">Unique Growth Opportunity: Gain hands-on experience across clinical studies, data analysis, regulatory submissions, and product development. </li><li style="margin-left:8px">Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.</li><li style="margin-left:8px">Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.</li><li style="margin-left:8px">Professional Development: Receive mentorship and opportunities to expand your technical and industry knowledge.</li><li style="margin-left:8px">Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.</li><li style="margin-left:8px">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</li><li style="margin-left:8px">You’ll have great perks such as: </li><li style="margin-left:8px">Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), </li><li style="margin-left:8px">Flexible vacation </li><li style="margin-left:8px">Kombucha and cold brew on tap, craft coffee, and a variety of healthy snacks</li></ul> WHAT YOU WILL DO Strategic Leadership<ul><li style="margin-left:8px">Develop and execute a unified, robust, and scalable data strategy to support clinical trials, R&D studies, and regulatory submissions.</li><li style="margin-left:8px">Build and mentor a high-performing team of data managers, database programmers, biostatisticians, and data scientists.</li><li style="margin-left:8px">Serve as a senior advisor to Clinical, R&D, and Regulatory leaders on data architecture, analytics, and evidence strategies.</li><li style="margin-left:8px">Ensure alignment of data architecture with business goals and regulatory requirements.</li><li style="margin-left:8px">Data Infrastructure and Systems Development</li><li style="margin-left:8px">Lead the design, integration, and governance of clinical databases and data pipelines from the ground up.</li><li style="margin-left:8px">Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools to harmonize internal and CRO data sources.</li><li style="margin-left:8px">Guide the creation of user-friendly tools for data input, extraction, and analysis across teams.</li><li style="margin-left:8px">Ensure compliance with 21 CFR Part 11, GCP, HIPAA, and other applicable data regulations. Hire, mentor, and manage a team of data professionals to support clinical and R&D initiatives.</li></ul> Clinical Data Management<ul><li style="margin-left:8px">Establish SOPs, standards, and templates for data collection, cleaning, reconciliation, and database lock.</li><li style="margin-left:8px">Direct data management activities for clinical studies, ensuring data quality, completeness, and traceability.</li><li style="margin-left:8px">Collaborate with CRO partners and central labs to ensure consistent data flow and integrity.</li><li style="margin-left:8px">Biostatistics & Data Science</li><li style="margin-left:8px">Provide strategic direction for statistical design, analysis, and interpretation of clinical and analytical validation studies.</li><li style="margin-left:8px">Oversee development of statistical analysis plans (SAPs) and ensure robustness of models and results.</li><li style="margin-left:8px">Guide exploratory and confirmatory data analyses, leveraging both traditional biostatistics and modern data science/ML techniques.</li><li style="margin-left:8px">Drive the development of data visualization dashboards and analytic tools to support real-time decision-making.</li></ul>Cross-Functional Collaboration<ul><li style="margin-left:8px">Partner with Clinical Operations, Regulatory Affairs, Quality, and Product Development teams to ensure alignment of data strategy with business goals.</li><li style="margin-left:8px">Support regulatory submissions (FDA, IVDR) through clear, validated, and reproducible data outputs.</li><li style="margin-left:8px">Translate complex data analyses into compelling, clear narratives for scientific and regulatory audiences.</li></ul> WHAT YOU WILL BRING Required:<ul><li style="margin-left:8px">Master’s or PhD in Biostatistics, Data Science, Biomedical Informatics, or related quantitative field.</li><li style="margin-left:8px">Minimum of 10 years of experience in clinical data management, biostatistics, or data science roles within diagnostics, medical devices, or pharmaceuticals</li><li style="margin-left:8px">Minimum of 5 years of management and leadership experience </li><li style="margin-left:8px">Proven experience building and leading data teams (data management, biostatistics, and informatics) from the ground up in a regulated environment.</li><li style="margin-left:8px">Demonstrated ability to design and integrate clinical databases and data pipelines across multiple systems and vendors. </li><li style="margin-left:8px">Strong command of SQL and relational databases (e.g., PostgreSQL, MS SQL Server).</li><li style="margin-left:8px">Deep understanding of FDA regulations, including 21 CFR Part 11, Part 820, GCP, ICH E6, and regulatory requirements for IVD data.</li><li style="margin-left:8px">Familiarity with EDC systems (Medidata, REDCap, etc.), data visualization tools (Tableau, Spotfire, Power BI), and data standards (CDISC/SDTM, HL7/FHIR).</li><li style="margin-left:8px">An analytical mindset with strong attention to detail and the ability to draw meaningful insights from complex datasets.</li><li style="margin-left:8px">Proactive, self-motivated, and eager to take ownership of tasks and learning opportunities.</li><li style="margin-left:8px">Exceptional communication skills and ability to translate complex statistical concepts and data into clear, actionable insights for technical and non-technical audiences.</li><li style="margin-left:8px">Comfortable working in a fast-paced, start-up environment with shifting priorities.</li></ul> Preferred:<ul><li style="margin-left:8px">Knowledge of cloud platforms (AWS, Azure) and data governance frameworks.</li><li style="margin-left:8px">Startup or small-company experience building infrastructure from scratch</li><li style="margin-left:8px">Prior experience supporting FDA submission data requirements for IVDs (e.g., 510(k), PMA, EUA). </li></ul> SALARY RANGE<ul><li style="margin-left:8px">$196,000 - $216,000 </li></ul>This range encompasses the diverse set of factors considered in making compensation decisions, including, but not limited to, experience, skills, knowledge, abilities, education, licensure, 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. HOW TO STAND OUT 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. Equal Opportunity Statement 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.  Powered by JazzHR

Director, Clinical Data Management & Data Science

Architectural Analysis

Assay Development

Assays

Biomedicine

Clinical Data

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Data Management

Clinical Information Systems

Clinical Practices/Protocols

Clinical Support

Code of Federal Regulations

Contract Research Organization (CRO)

Data Analysis

Data Cleaning

Data Collection

Data Entry

Data Management

Data Science

Data Sets

Data Visualization

Data Visualization Tools

Data Warehousing

Database Design

Database Programming

Detail Oriented

Ecosystems

Electronic Data Capture (EDC)

FDA Requirements

GCP (Good Clinical Practices)

HIPAA (Health Insurance Portability and Accountability Act)

HL7 (Health Level 7)

Healthcare Quality

ICH Regulations

Informatics

Insurance

Laboratory Information Management System (LIMS)

Maintain Compliance

Medical Equipment

Mentoring

Microsoft SQL Server

Patient Care

PostgreSQL

Power BI

Reconciliation

Regulatory Requirements

Relational Databases (RDBMS)

Reporting Dashboards

Research & Development (R&D)

SQL Databases

Small Company

Standard Operating Procedures (SOP)

Strategic Planning

Surveillance

System Validation

Tableau

Team Lead/Manager

Team Player

Test Suite

Tibco Spotfire

Traceability

User Documentation

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Staff BiostatisticianTruvian Sciences

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