Data Scientist (Biostatistics) - Remote, USA

The role

This person will transform real-world, clinical, and preclinical data into reliable datasets, analyses, and insights. They will support evidence generation across the medical device product lifecycle through statistical programming, study design, and data analysis.

What you will do

• Translate research and business questions into cohort definitions, data requirements, and analytic plans.
• Work with real-world data, EHR records, claims data, and clinical data.
• Build, validate, and maintain reproducible workflows for data extraction and analysis.
• Develop workflows for structured clinical data and unstructured notes using natural language processing.
• Support real-world evidence and post-market analyses to evaluate device safety and performance.
• Provide biostatistical support for preclinical and clinical studies including study design and endpoints.
• Support development of Statistical Analysis Plans, programming specifications, and analysis datasets.
• Review study data for quality, completeness, and consistency.
• Perform and quality-check descriptive and inferential analyses.
• Interpret and communicate results for study reports, regulatory submissions, and publications.

Required qualifications

• Bachelor’s degree in data science, statistics, biostatistics, computer science, epidemiology, public health, or a related quantitative field, plus 7 years of relevant experience; or a master’s degree
• Practical experience using R to prepare, analyze, visualize, and validate complex datasets.
• Experience translating a research question into a well-defined dataset, analysis plan, and transparent, reproducible analytical workflow.
• Experience with statistical analysis of clinical, preclinical, observational, or other health-related data.
• Working knowledge of study design, endpoint definition, analysis planning, and interpretation of clinical or preclinical study data.
• Ability to develop, review, and document statistical programs and analytical outputs with appropriate quality control and traceability.
• Strong data-quality, documentation, problem-solving, and communication skills.
• Ability to work independently while collaborating effectively in a cross-functional team environment.

Nice to have

• Master’s degree or PhD in biostatistics, statistics, epidemiology, data science, or a related quantitative field.
• Familiarity with SAS, Python, and SQL.
• Experience with real-world data, EHR records, claims data, clinical trial data, or other longitudinal healthcare data.
• Familiarity with observational study methods and real-world evidence generation.
• Experience with clinical text, natural language processing, regular expressions, or clinical concept extraction.
• Experience supporting preclinical or clinical study design, statistical analysis plans, sample size or precision calculations, or statistical reporting.
• Experience creating Tables, Listings, and Figures or contributing to clinical study reports, publications, abstracts, posters, or regulatory submissions.
• Experience working in a medical-device, clinical-research, pharmaceutical, or other regulated environment.
• Familiarity with applicable clinical research and data standards, including GCP, ISO 14155, ICH E9, and relevant FDA guidance.
• A passion for turning complex data into reliable evidence that supports better decisions and patient impact.

Benefits

• Competitive base salary
• Variable incentive plan
• Stock options
• 401(k)
• Healthcare insurance
• Paid vacation

Before you apply

• Legal authorization to work in the United States is required.
• Hiring process includes multiple stages of interviews.
• Candidates must meet virtually or in person to receive job offers.

About the company

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment.