Statistical Programmer / Data Scientist (Digital Health Validation)

Billennium; Polska; On-site; PLN 150,000 - 230,000; Full time

Benefits offered by this job

B2B model

Private healthcare

Multisport card

Life insurance

Language courses

Online learning platforms

International teams

Job summary

Billennium is seeking a statistician with 4+ years of experience to join an international team working on digital health solutions. You will lead analytical validation, clinical validation, and regulatory-focused analyses for devices and biomarkers.

You will collaborate with Clinical, Regulatory, Engineering, and Data Science teams, ensuring compliant SAPs, TLFs, and regulatory evidence packages are produced to support submissions.

Qualifications

• MSc or PhD in Statistics, Biostatistics, Data Science, Mathematics or Computer Science.
• Minimum 4 years of professional experience in statistical programming, biostatistics, clinical analytics, or data science.
• Experience supporting FDA/EMA submissions.
• Advanced Python programming.
• Strong knowledge of analytical/clinical validation frameworks.
• Experience with CDISC SDTM/ADaM data standards.
• Regulated environments (GCP, 21 CFR Part 11) familiarity.

Responsibilities

• Author and execute SAPs for Analytical Validation and Clinical Validation.
• Design statistical methods analyzing device reliability, agreement, accuracy and clinical relevance.
• Develop validated, regulatory-grade analyses and generate TLFs.
• Perform statistical programming supporting validation activities for DHTs.
• Prepare and transform clinical data to CDISC SDTM/ADaM.
• Ensure compliance with regulatory requirements and document regulatory evidence.
• Prepare validation reports and regulatory submission packages.
• Collaborate with Clinical, Regulatory, Engineering, and Data Science teams as SME.
• Support regulatory submissions and responses.
• Maintain high standards of code quality, reproducibility, and documentation.

Skills

Python

Statistical programming

Biostatistics

Regulatory compliance

CDISC SDTM/ADaM

Pandas

NumPy

SciPy

Scikit-learn

Git

Regulatory submissions

Education

MSc/PhD in Statistics/Biostatistics/Data Science/Math/CS

Tools

Pandas

NumPy

SciPy

Scikit-Learn

Git

Job description

About the Project

You will become part of an international team working on innovative digital solutions used to monitor disease progression and treatment effectiveness in clinical studies.

The focus of this role is the statistical validation of Digital Health Technologies (DHTs) and digital biomarkers, helping ensure they meet the rigorous standards required for use in clinical trials and regulatory submissions.

You will work closely with Clinical, Regulatory, Engineering, and Data Science teams, contributing to analytical validation, clinical validation, and preparation of evidence supporting regulatory acceptance of innovative healthcare technologies.

Your Responsibilities

• Author and execute Statistical Analysis Plans (SAPs) for Analytical Validation (AV) and Clinical Validation (CV) activities.
• Design and implement statistical methodologies assessing device reliability, agreement, accuracy, and clinical relevance.
• Develop validated, regulatory-grade statistical analyses and generate Tables, Listings, and Figures (TLFs).
• Perform statistical programming and analysis supporting validation activities for Digital Health Technologies.
• Prepare and transform clinical data according to CDISC SDTM and ADaM standards.
• Ensure compliance with regulatory requirements, including FDA, EMA, GCP, and 21 CFR Part 11.
• Prepare validation reports, statistical documentation, and regulatory evidence packages.
• Collaborate with Clinical, Regulatory, Engineering, and Data Science teams as the statistical subject matter expert.
• Support regulatory submissions and responses related to statistical validation activities.
• Maintain high standards of code quality, reproducibility, and documentation.

What We're Looking For

Must Have

• MSc or PhD degree in Statistics, Biostatistics, Data Science, Mathematics, Computer Science, or another quantitative discipline.
• Minimum 4 years of professional experience in statistical programming, biostatistics, clinical analytics, or Data Science within pharmaceutical companies, MedTech organizations, CRO environments, or other healthcare-related industries.
• Experience supporting FDA and/or EMA submissions.
• Strong understanding of Analytical Validation, Clinical Validation, clinical trial methodologies, and statistical validation frameworks.
• Experience working in regulated environments following GCP, 21 CFR Part 11, and other regulatory compliance standards.
• Advanced programming skills in Python.
• Strong knowledge of statistical methods including Bland-Altman Analysis, Intraclass Correlation Coefficient (ICC), Lin’s Concordance Correlation Coefficient (CCC), Kappa Statistics, Limits of Agreement, Regression Models, Mixed-Effects Models, and Psychometric Validation Methods.
• Hands‑on experience with Pandas, NumPy, SciPy, Statsmodels, and Scikit‑Learn.
• Experience working with CDISC SDTM and ADaM data standards.
• Experience preparing SAPs, Tables, Listings and Figures (TLFs), Validation Reports, and Regulatory Submission Packages.
• Strong understanding of software development best practices, including Git, GitHub, unit testing, code reviews, and SDLC processes.

Nice to Have

• Experience with R and related statistical packages.
• Experience working with Digital Health Technologies (DHTs).
• Knowledge of wearable device data and digital endpoint methodologies.
• Experience working in international and cross‑functional teams.
• Familiarity with machine learning techniques applied to healthcare, clinical research, or digital health products.

Who Are We Looking For?

We are looking for someone who:

• Has a strong analytical and scientific mindset.
• Is passionate about applying statistics to real‑world healthcare challenges.
• Can balance methodological rigor with practical business and regulatory requirements.
• Pays close attention to detail and data quality.
• Communicates complex statistical concepts clearly to both technical and non‑technical audiences.
• Works effectively in multidisciplinary environments.
• Takes ownership of deliverables and drives initiatives to completion.
• Enjoys collaborating with experts across clinical, regulatory, engineering, and data science domains.

What We Offer

• Cooperation in a B2B model.
• Benefits package for contractors (private healthcare, Multisport card, life insurance, language courses, and access to online learning platforms).
• Opportunity to contribute to cutting‑edge Digital Health Technologies used in clinical research.
• Participation in projects that directly influence the future of healthcare and drug development.
• Collaboration with international teams of Data Scientists, Statisticians, Clinical Experts, Regulatory Specialists, and Engineers.
• Exposure to innovative digital biomarker and validation initiatives.
• Long‑term cooperation in a highly innovative, science‑driven environment.
• A culture that values collaboration, scientific excellence, continuous learning, and professional growth.