Statistical Programmer / Data Scientist (pharma; 100% remote)

About project We are seeking a rigorous and detail-oriented Statistical Programmer / Data Scientist dedicated to the statistical validation of our Digital Health Technologies (DHTs). In this role, your primary focus will be authoring comprehensive Statistical Analysis Plans (SAPs) and executing the regulatory-grade programming required for Analytical Validation (AV) and Clinical Validation (CV) within the V3 framework. 100% remote work.

Tasks

Statistical Analysis Plans (SAPs) & Validation Design

Analytical Validation (AV) SAPs: Co-author rigorous SAPs to demonstrate that the DHT reliably and accurately measures physiological metrics compared to a gold-standard reference device (e.g., defining methodologies like Bland-Altman analysis, Lin’s Concordance Correlation Coefficient, and Limits of Agreement).

Clinical Validation (CV) SAPs: Co-design SAPs to evaluate the DHT's ability to measure clinically meaningful concepts within a specific context of use, utilizing appropriate longitudinal, mixed-effects, or psychometric statistical models.

Statistical Methodology: Select, justify, and document the appropriate statistical methods and success criteria required to meet FDA and EMA evidence expectations for DHT validation.

Regulatory-Grade Programming & Code Quality

Reproducible Execution: Write clean, modular, and highly documented code in Python (or in exceptions in R) to execute the SAPs, generating the necessary derived datasets, Tables, Listings, and Figures (TLFs) for regulatory submission.

Code Validation & SDLC: Implement rigorous software development best practices, including version control (Git), automated unit testing, and peer code reviews, ensuring zero-defect statistical outputs.

Traceability & Compliance: Ensure all analytical pipelines, environments, and codebases comply with 21 CFR Part 11, Good Clinical Practice (GCP), and internal Standard Operating Procedures (SOPs) for software and statistical validation.

Data Standards: Map raw and processed DHT data into regulatory-compliant data structures (e.g., CDISC SDTM/ADaM) to facilitate seamless FDA review.

Regulatory Submissions & Documentation

Evidence Packages: Compile and structure the final statistical reports, code packages, and validation documentation required for FDA review (e.g. DDT or IND pathways).

Audit Readiness: Maintain comprehensive documentation detailing data lineage, programming specifications, and statistical methodologies so that all validation evidence is entirely transparent and audit-ready.

Cross-Functional Collaboration & Communication: Act as a statistical subject matter expert, effectively communicating complex statistical methodologies and validation results to cross-functional teams (Clinical, Regulatory, Engineering)

Expectations

Degree: M.

S. or Ph.

D. in Biostatistics, Statistics, Data Science, or a related quantitative field.

Experience: 4+ years of industry experience in a pharmaceutical, medical device, or CRO environment, specifically focused on clinical trial statistics, SAP authoring, and statistical programming.

Regulatory Exposure: Direct experience preparing statistical evidence for regulatory bodies (FDA, EMA), particularly in demonstrating the reliability and validity of clinical assessments or devices.

Validation Statistics: Deep expertise in statistical methods used for method comparison, agreement, and reliability (e.g., convergent/divergent validity, ICC, Kappa, Bland-Altman, regression models for continuous and categorical outcomes).

Programming Languages: Expert-level proficiency in statistical programming in Python (or in exceptions R)

Code Quality Tools: Mastery of version control (Git/GitHub) and statistical programming validation frameworks.

Optional - Regulatory Frameworks: Thorough understanding of the V3 framework (specifically Analytical and Clinical Validation) and the FDA’s guidance on the use of DHTs for Remote Data Acquisition in Clinical Investigations.

Clinical Data Standards: Strong working knowledge of CDISC standards (SDTM, ADaM) (Optional: and how they apply to high-frequency or non-traditional digital health data).

We offer

Ongoing support from a dedicated agent, taking care of your project continuity, client contact, necessary formalities, work comfort and development, Consultant Development Program – advice on growth planning based on the latest trends and market needs in IT, including consultations with agents and growth mentors, Access to 7N Learning & Development – a development and educational platform with webinars, a library of articles and industry reports, and regular invitations to one-time and recurring development events – technical, business, and lifestyle, Spectacular integration events, both for you (e.g., annual Kick-Off trip, Christmas parties, or Summer Olympics sports events) and for your loved ones (e.g., family picnics, movie premieres), Professional development not only during the project – you can get involved in knowledge transfer to others within the 7N Services offering directed at 7N clients, Relationships and access to the knowledge of the most experienced IT experts in the market – the average professional tenure of our consultants in Poland is over 10 years, A complete benefits package, including funding for medical care, life insurance, sports cards for you and your loved ones, as well as discounts in stores in Poland and abroad.

About 7NConstantly searching for projects, difficult rate negotiations, lack of development support – sounds familiar? At 7N, you gain not only stability of contracts but also the personal involvement of a dedicated agent who ensures your professional comfort and continuous access to development initiatives.

Our mission is to provide stable and rewarding collaborations that drive your success as an IT expert and the success of our clients. We build long-lasting relationships based on Scandinavian values and 30 years of experience creating IT solutions for over 200 organizations.