Data Scientist - Statistical Programmer (f/m/x)

November 6, 2026

Remote

Senior

Warsaw, Poland

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English is required

Description

Detail-oriented Statistical Programmer role focused on the statistical validation of Digital Health Technologies. The specialist authors Statistical Analysis Plans and executes regulatory-grade programming in Python or R for Analytical and Clinical Validation. The work is remote, with collaboration with cross-functional teams to ensure compliance with FDA and EMA standards.

Gender markers in the title: (f/m/x)

In accordance with European anti-discrimination legislation, this job is open to all candidates

Ffemale

Mmale

Xintersex

Responsibilities

Designing Statistical Analysis Plans for Clinical Validation to assess the Digital Health Technologies' capability in measuring clinically meaningful concepts using appropriate statistical models
Selecting and documenting suitable statistical methods and success criteria to meet FDA and EMA validation requirements
Writing clean, modular, and well-documented code in Python (or R) to generate necessary datasets and statistical outputs for regulatory submission
Implementing software development best practices, including version control and automated testing, to ensure high-quality statistical programming outputs
Ensuring compliance with regulatory standards, including 21 CFR Part 11 and Good Clinical Practice (GCP), throughout the statistical validation process
Mapping raw and processed DHT data into CDISC-compliant data structures to facilitate efficient FDA review
Compiling and structuring statistical reports and validation documentation for regulatory submissions, ensuring audit readiness

Requirements

Master's or Ph.D. in Biostatistics, Statistics, Data Science, or a related quantitative field
Minimum 6 years of experience in statistical programming or data science within the pharmaceutical, medical device, or CRO sectors, with a focus on clinical trial statistics and SAP authoring
Advanced proficiency in Python for statistical programming, with a strong understanding of best practices in software development, such as Git and unit testing
Expertise in validation statistics and methods for assessing measurement agreement, including Bland-Altman analysis and mixed-effects models
Experience preparing statistical evidence for regulatory bodies such as the FDA and EMA, particularly in the context of clinical assessments
Advanced level of English
Poland as a current place of living