Data Scientist (Biostatistics) - Remote, USA

We are seeking a Data Scientist to support evidence generation across the medical device product lifecycle. This role, under the direction of the Manager of Biostatistics & Data Science, will transform real-world, clinical, and preclinical data into reliable, reproducible datasets, analyses, and insights that support research and cross functional business needs. The ideal candidate brings strong hands-on data science and statistical skills, with the ability to translate research questions into fit-for-purpose datasets and analytical approaches. The role will support both real-world data initiatives and the statistical execution of preclinical and clinical studies. This individual will work closely with Scientific, Clinical, R&D, Regulatory, Quality, IT, and external data partners. Reports to: Manager, Biostatistics.

Responsibilities

Translate research and business questions into cohort definitions, data requirements, analytic plans, and clear deliverables; Work with real-world data, EHR records, claims data, and clinical data to assess availability, provenance, quality, and suitability for analysis; Build, validate, and maintain reproducible workflows for data extraction, transformation, cohort construction, data-quality checks, and analysis-ready datasets; Develop and validate workflows for structured clinical data and unstructured notes, including clinical concept extraction and NLP where appropriate; Support real-world evidence and post-market analyses, including trend assessments, subgroup analyses, evidence synthesis, and device safety and performance analyses; Provide biostatistical support for preclinical and clinical studies, including input on protocols, study design, endpoints, analysis populations, sample size, and data collection; Support development and maintenance of Statistical Analysis Plans, programming specifications, analysis datasets, table shells, and analysis documentation; Review study data for quality, completeness, consistency, and alignment with planned analyses; Perform and quality-check descriptive and inferential analyses, including interim, final, sensitivity, and subgroup analyses; Interpret and communicate results and contribute to study reports, clinical evaluation materials, regulatory submissions, publications, abstracts, posters, and presentations; Build and implement data workflows with internal IT and external data partners following established data access, storage, and transfer processes; Maintain clear documentation of data definitions, source systems, transformations, statistical methods, assumptions, quality checks, and results; Apply quality-control practices to datasets, analyses, programs, and outputs; Contribute to standards, templates, workflows, and best practices for data science and biostatistics; Translate complex statistical concepts into clear explanations for technical and nontechnical stakeholders; Present analytical findings, assumptions, limitations, and recommendations to project teams; Contribute to a collaborative, accountable, and scientifically rigorous team environment

Requirements

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 in a related field, plus 5 years of relevant experience; 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; Full-time employment; Ability to travel up to 10% of the time

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 GCP, ISO 14155, ICH E9, and relevant FDA guidance; Passion for turning complex data into reliable evidence; Solution-focused mindset; Careful attention to detail and commitment to reproducibility, transparency, and scientific rigor; Curiosity and adaptability; Ability to communicate clearly and collaborate generously

Benefits

Attractive compensation package; Variable incentive plan; Stock options; Employee benefits package including 401(k); Healthcare insurance; Paid vacation