Biostatistician - REMOTE

Brisbane, CA

Full Time Senior-level / Expert
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Caption Health

Our mission is to detect disease early—when there is the highest potential for impact—by leveraging artificial intelligence and ultrasound.
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About Caption Health
Caption Health’s mission is to detect disease early – when there is the highest potential for impact – by leveraging artificial intelligence and ultrasound. Our breakthrough AI platform enables any healthcare professional to perform high-quality ultrasound exams for early disease detection, in convenient and lower-cost outpatient settings including patients’ homes. It was recognized as one of TIME’s 100 Best Inventions of 2021 and one of Fast Company’s Next Big Things in Health Tech.
Through our work with health plans, providers, patients, and industry partners, we are transforming care, expanding access, and reducing costs.
To learn more, visit captionhealth.com.
We are seeking a Biostatistician to add expertise to our Product team! You will be responsible for clinical and regulatory strategy, establishing methods/processes for validating product performance, and assuring validation and verification (V & V) efforts for a wide variety of deep neural network & machine learning models for the purpose of regulatory clearance and subsequent ML model improvement.

Responsibilities:

  • Prepare and present statistical reports and data visualizations to non-statisticians, exchange information of facts, statuses, ideas, issues etc. to achieve objective, and influence decision-making.
  • Lead the design, plan and conduct of statistical components in research and development projects that establish the conditions essential for demonstrating safety, efficacy and marketability of products.
  • Prepare the statistical component of protocols and / or statistical analysis plans and reports. Support the regulatory review and approval of medical devices.
  • Support the development of clinical research and regulatory clearance strategy at individual product level and at the company-wide level based on current clinical practice and regulatory practice.
  • Closely collaborate with clinical, development and regulatory teams  to provide informed, creative, and effective solutions to the many challenges the team faces in getting products through to commercial release.
  • Establish the performance testing methods/metrics by taking a balanced account of the clinical problem, the product developed to solve the clinical problem, practical/technical constraints, and the regulatory practice.
  • Oversee & manage product - performance tests. Ensure the completion of the performance test plans and reports, which can involve hands-on contribution.
  • Keep up-to-date with ever changing regulatory practice and standards.
  • Perform other duties as assigned.

Requirements:

  • 4+ years of combined academic and/or industry experience in medical device/software clinical and regulatory affairs.
  • Hands-on experience on designing scientific experiments with hypothesis testing.
  • Hands-on experience on evaluating/developing performance testing methodologies of medical devices.
  • A bachelor's degree in a scientific discipline or technical field, or equivalent.
  • Experience as working as a scientist / biostatistician in a corporate environment or in a government agency.
  • A master's or Ph.D. degree in a relevant field.
  • Experience in a startup environmentDeep knowledge of statistics and statistical principles.
  • Knowledge of regulatory requirements governing clinical trials e.g., Good Clinical Practices (GCP) and / or regulatory compliance guidelines (e.g., ISO, MDR, CFR).
  • Ability to work in a dynamic entrepreneurial environment where job descriptions are not narrow and all team members take an expansive view of their individual responsibilities.
  • Ability to exercise independent judgment in devising regulatory plans and actions.
  • Experience handling regulated medical technology products with significant software components, specifically deep neural network and machine learning models.
  • Strong teamwork ethic, communication skills, and passion for learning.
  • Strong background in statistical and analysis (statistical modeling, statistical inference, adaptive design).
  • Proficient with Microsoft 365 or similar software.

  • Bonus:
  • Familiarity and/or experience with Computer-Aided Detection/Diagnosis (CADe/CADx) and regulatory approaches.

Caption Health is an Equal Employment Opportunity employer that proudly pursues and hires a diverse workforce. Caption Health does not make hiring or employment decisions on the basis of race, color, religion or religious belief, ethnic or national origin, nationality, sex, gender, gender-identity, sexual orientation, disability, age, military or veteran status, or any other basis protected by applicable local, state, or federal laws or prohibited by Company policy. Caption Health. strives for a healthy and safe workplace and strictly prohibits harassment of any kind. Pursuant to the San Francisco Fair Chance Ordinance and other similar state laws and local ordinances, and its internal policy.

Tags: Clearance Compliance Entrepreneurial GCP Machine Learning Research Statistical modeling Statistics

Perks/benefits: Startup environment

Region: Asia/Pacific
Country: Australia
Job stats:  0  0  0
Category: Other Jobs
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