Senior Statistical Programmer / Data Scientist
New
A
AvengaDigital health
Workplace type: remote; Locations: Warszawa, Przyokopowa, Warszawa, Country code: PLContractSenior
Salary160 - 170 PLN per month
Apply NowOpens the employer's application page
Job Details
- Experience
- 4+ years of industry experience
- Required Skills
- PythonGitRGitHub
Requirements
- Have 4+ years of industry experience in a pharmaceutical, medical device, or CRO environment focused on clinical trial statistics, SAP authoring, and statistical programming.
- Have direct experience preparing statistical evidence for regulatory bodies, including FDA and EMA.
- Bring expertise in method comparison, agreement, and reliability statistics, including convergent/divergent validity, ICC, Kappa, Bland-Altman, and regression models for continuous and categorical outcomes.
- Demonstrate expert-level statistical programming proficiency in Python; R may be used in exceptions.
- Have mastery of version control using Git/GitHub and statistical programming validation frameworks.
- Have strong working knowledge of CDISC SDTM and ADaM standards.
- Understand the V3 framework, particularly Analytical and Clinical Validation (optional).
- Understand FDA guidance on DHTs for Remote Data Acquisition in Clinical Investigations (optional).
Responsibilities
- Co-author Statistical Analysis Plans for analytical validation against gold-standard reference devices.
- Co-design Statistical Analysis Plans for clinical validation using appropriate longitudinal, mixed-effects, or psychometric models.
- Select, justify, and document statistical methods and success criteria for FDA and EMA evidence expectations.
- Write documented, modular Python code (or R in exceptions) to execute SAPs and generate derived datasets, tables, listings, and figures.
- Apply version control, automated unit testing, and peer code reviews.
- Maintain analytical pipelines, environments, and codebases in compliance with 21 CFR Part 11, GCP, and internal SOPs.
- Map raw and processed digital health technology data to CDISC SDTM/ADaM structures.
- Compile statistical reports, code packages, and validation documentation for FDA review.
- Maintain audit-ready documentation of data lineage, programming specifications, and statistical methodologies.
- Communicate statistical methodologies and validation results to Clinical, Regulatory, and Engineering teams.
View Full Description & ApplyYou'll be redirected to the employer's site
