Statistical Programmer / Data Scientist
New
7
7N Sp. z o. o.Digital health
100% remote work.ContractSenior
Salary26040 - 28560 PLN per month net b2b
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Job Details
- Experience
- 4+ years of industry experience in a pharmaceutical, medical device, or CRO environment
- Required Skills
- PythonR
Requirements
- M.S. or Ph.D. in Biostatistics, Statistics, Data Science, or a related quantitative field.
- 4+ years of industry experience in a pharmaceutical, medical device, or CRO environment.
- Experience focused on clinical trial statistics, SAP authoring, and statistical programming.
- Direct experience preparing statistical evidence for regulatory bodies, including FDA and EMA.
- Expertise in method comparison, agreement, and reliability statistics, including ICC, Kappa, Bland-Altman, and regression models for continuous and categorical outcomes.
- Expert-level proficiency in statistical programming with Python; R may be used in exceptions.
- Mastery of version control with Git/GitHub and statistical programming validation frameworks.
- Strong working knowledge of CDISC SDTM and ADaM standards.
- Thorough understanding of the V3 framework and FDA guidance on DHTs for Remote Data Acquisition in Clinical Investigations is optional.
Responsibilities
- Co-author Statistical Analysis Plans for analytical validation of digital health technologies against gold-standard reference devices.
- Co-design Statistical Analysis Plans for clinical validation in specific contexts of use.
- Select, justify, and document statistical methods and success criteria for DHT validation evidence.
- Write documented, modular Python code, or R in exceptions, to execute Statistical Analysis Plans.
- Generate derived datasets, Tables, Listings, and Figures for regulatory submissions.
- Apply version control, automated unit testing, and peer code reviews.
- Ensure analytical pipelines, environments, and codebases comply with 21 CFR Part 11, GCP, and internal SOPs.
- Map DHT data to regulatory-compliant structures such as CDISC SDTM and ADaM.
- Compile statistical reports, code packages, and validation documentation for FDA review.
- Communicate statistical methods and validation results to clinical, regulatory, and engineering teams.
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