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

We are seeking a detail-oriented Statistical Programmer to join our team focused on the statistical validation of Digital Health Technologies. In this role, you will be responsible for authoring comprehensive Statistical Analysis Plans and executing regulatory-grade programming necessary for Analytical and Clinical Validation. You will work remotely, collaborating with cross-functional teams to ensure compliance with FDA and EMA standards. If you have a passion for applying statistical methods to enhance healthcare technologies, we encourage you to apply.
Your tasks
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
Job no. JOB-WP33K
Sii ensures that all hiring decisions are made solely on the basis of qualifications and competence. We are committed to equal and fair treatment of all, regardless of legally protected characteristics. At Sii, we promote a diverse and inclusive work environment, in full compliance with applicable anti-discrimination laws.
Benefits For You
Great Place to Work
Solid financial situation
Contracts with the biggest brands
Centre of internal trainings
Many experts you can learn from
Open and accessible management team
Profit sharing
Passion Sponsorship program
Regular integration events and trips
Comfortable and well-equipped offices
MySii app
Medical care

Work arrangement
Yes