Data Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in generating evidence throughout the medical device product lifecycle.

• Convert real-world, clinical, and preclinical data into dependable, reproducible datasets, analyses, and insights.

• Interpret research and business inquiries into cohort definitions, data needs, analytic plans, and deliverables.

• Evaluate the availability, provenance, quality, and relevance of real-world data, EHR records, claims data, clinical data, and other sources.

• Create, validate, and maintain reproducible workflows for data extraction, transformation, cohort construction, data-quality assessments, and analysis-ready datasets.

• Develop, validate, and document workflows for structured clinical data and unstructured notes, including clinical concept extraction and NLP as needed.

• Facilitate real-world evidence and post-market analyses, incorporating trend, subgroup, and evidence-synthesis analyses.

• Provide biostatistical assistance for preclinical and clinical studies, covering protocols, study design, endpoints, analysis populations, sample size or precision considerations, and data-collection strategies.

• Support Statistical Analysis Plans, programming specifications, analysis datasets, table shells, and analysis documentation.

• Review study data and structures for quality, completeness, consistency, and alignment with planned analyses; identify and coordinate resolution of issues.

• Conduct and quality-check descriptive, inferential, interim, final, sensitivity, subgroup, and study-specific analyses.

• Interpret and communicate results, contributing to study reports, clinical evaluation documents, regulatory submissions, publications, abstracts, posters, and presentations.

• Construct and implement secure data workflows in collaboration with IT and external data partners, addressing access, storage, audit logging, permitted use, onboarding, and data transfer.

• Maintain comprehensive documentation of data definitions, source systems, transformations, statistical methods, assumptions, quality checks, and results.

• Employ quality-control practices and escalate significant issues and risks.

• Contribute to standards, templates, workflows, and best practices for data science and biostatistical analyses.

• Present analytical findings, assumptions, limitations, and recommendations to project teams and internal stakeholders.

• Report to the Manager of Biostatistics.

⛳️ Requirements

• Bachelor's degree in data science, statistics, biostatistics, computer science, epidemiology, public health, or a related quantitative field, along with 7 years of relevant experience; or a master's degree in a related field, with 5 years of relevant experience.

• Hands-on experience with R for preparing, analyzing, visualizing, and validating complex datasets.

• Experience in translating research questions into clearly defined datasets, analysis plans, and transparent, reproducible analytical workflows.

• Background in statistical analysis of clinical, preclinical, observational, or other health-related data.

• Familiarity with study design, endpoint definition, analysis planning, and interpretation of clinical or preclinical study data.

• Capability to develop, review, and document statistical programs and analytical outputs with proper quality control and traceability.

• Strong skills in data quality, documentation, problem-solving, and communication.

• Ability to work autonomously while effectively collaborating in a cross-functional team setting.

• Full-time employment commitment.

• Willingness to travel up to 10% of the time.

• Legal authorization to work in the United States is mandatory.

• Preferred: Master's degree or PhD in biostatistics, statistics, epidemiology, data science, or a related quantitative field.

• Preferred: Knowledge of SAS, Python, and SQL.

• Preferred: Experience with real-world data, EHR records, claims data, clinical trial data, or other longitudinal healthcare data.

• Preferred: Understanding of observational study methods and real-world evidence generation.

• Preferred: Familiarity with clinical text, natural language processing, regular expressions, or clinical concept extraction.

• Preferred: Experience in supporting preclinical or clinical study design, statistical analysis plans, sample size or precision calculations, or statistical reporting.

• Preferred: Experience in creating Tables, Listings, and Figures or contributing to clinical study reports, publications, abstracts, posters, or regulatory submissions.

• Preferred: Experience in a medical-device, clinical-research, pharmaceutical, or other regulated environment.

• Preferred: Familiarity with relevant clinical research and data standards, including GCP, ISO 14155, ICH E9, and applicable FDA guidance.

🏝️ Benefits

• Variable incentive plan.

• Stock options.

• 401(k).

• Healthcare insurance.

• Paid vacation.

• Continuous learning and dynamic challenges for professional development.

• Diverse work environment with experienced leadership.

• Opportunity to influence company culture.