Senior Statistical Programmer for 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

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.