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 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
Recruitment stages
Send your CV
Talk to us about your expectations
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Start your adventure with Sii!
Sii Sp. z o.o.
Sii is the leading technology consulting, digital transformation, engineering, and business services vendor in Poland. We already employ more than 7 300 professionals and implement projects in a variety of industries for clients from many countries around the world. The Great Place to Work title, won 10 times in a row, proves that at Sii, we create a friendly work environment.
Sii ensures that all employment-related decisions are made solely on the basis of qualifications and competencies. We are committed to equal treatment of all individuals, regardless of any protected characteristics, and promoting a diverse and inclusive work environment.
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