Clinical Data Scientist

Location Cracow & Remote

Region / State / Province Kraków; Remote

Offer description

At Ardigen, we apply the power of Artificial Intelligence to accelerate the development of precision therapies. As we expand into the clinical domain, we’re seeking a Clinical Data Scientist / Biostatistician to support the transition from preclinical research to clinical trials.

This role is ideal for a scientist who thrives in a regulated, detail-oriented environment and is ready to take ownership of statistical analysis and reporting in clinical research. You’ll play a key role in formalizing analysis plans, interpreting clinical data, and ensuring alignment with GxP and CDISC standards.

Let's grow together & code against cancer!

Key duties and responsibilities

Design and implement statistical analysis plans (SAPs), ensuring alignment with endpoints, clinical protocols, and regulatory expectations.
Perform statistical analyses using STDM and ADaM datasets; generate high-quality outputs including TLFs (tables, listings, figures).
Maintain traceability and clarity in analysis documentation, ensuring consistency and full formalization.
Review and validate statistical outputs, ensuring adherence to GxP, CDISC (e.g., STDM, ADaM), and internal quality standards.
Collaborate closely with data managers, medical writers, and clinical scientists to support clinical study design and execution.
Ensure proper documentation and compliance across all analysis processes.
Support audits and inspections by preparing well-structured, regulatory-compliant statistical files.

Requirements

Solid experience in clinical biostatistics, ideally within a pharmaceutical, CRO, or biotech setting.
Strong understanding of GxP guidelines and statistical standards in clinical trials.
Hands-on experience with CDISC standards, including STDM and ADaM data structures.
Proficiency in statistical programming (e.g., SAS, R) and ability to produce submission-ready outputs using Pharmaverse.
Proven ability to write and implement SAPs, with attention to detail and documentation style.
Familiarity with clinical trial phases, endpoints, and regulatory requirements.
Ability to work cross-functionally in dynamic, multidisciplinary teams.
Strong problem-solving and communication skills.
Fluency in English, both written and spoken.
Familiarity with estimands and the sensitivity analysis framework
Knowledge of real-world data (RWD) and real-world evidence (RWE) approaches, especially for late-phase studies.

We offer

Flexible working hours
Employee Stock Option Plan
Mental health support (HearMe Platform)
English classes
Funding for professional development, training, and an internal mentoring program
The opportunity to not just code, but to code with a purpose to make a difference - making a meaningful impact through your daily work #CodeAgainstCancer
Private medical care
Multisport card