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

Technologies we use

About the project

Your 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

Our 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

What we offer

• Great Place to Work since 2015 - it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas
• Employment stability - revenue of PLN 2.1BN, no debts, since 2006 on the market
• We share the profit with Workers - over PLN 76M has already been allocated for this aim since 2022
• Attractive benefits package - private healthcare, benefits cafeteria platform, car discounts and more
• Comfortable workplace – class A offices or remote work
• Dozens of fascinating projects for prestigious brands from all over the world – you can change them thanks to Job Changer application
• PLN 1 000 000 per year for your ideas - with this amount, we support the passions and voluntary actions of our workers
• Investment in your growth – meetups, webinars, training platform and technology blog – you choose
• Fantastic atmosphere created by all Sii Power People