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

7N provides stable and rewarding collaborations with dedicated agent support, focusing on the success of IT experts and clients. They have 30 years of experience creating IT solutions for over 200 organizations based on Scandinavian values.

• M.S. or Ph.D. in Biostatistics, Statistics, Data Science, or a related quantitative field.
• 4+ years industry experience in pharmaceutical, medical device, or CRO settings with focus on clinical trial statistics, SAP authoring, and statistical programming.
• Experience preparing statistical evidence for FDA and EMA regulatory submissions.
• Expertise in method comparison statistics, reliability metrics, and regression models for outcomes.
• Expert-level proficiency in statistical programming in Python and occasionally R.
• Mastery of version control systems (Git/GitHub) and statistical programming validation frameworks.

Nice to have:

• Knowledge of the V3 framework for Analytical and Clinical Validation.
• Strong understanding of CDISC standards (SDTM, ADaM), including applications for digital health data.

Statistical Analysis Plans (SAPs) & Validation Design:

• Co-author SAPs demonstrating DHT reliability against reference devices using methods like Bland-Altman analysis and Lin’s Concordance Correlation Coefficient.
• Co-design SAPs evaluating DHT's clinical measurement capabilities using longitudinal and mixed-effects statistical models.
• Select and document appropriate statistical methods meeting FDA and EMA evidence criteria.

Regulatory-Grade Programming & Code Quality:

• Write clean, modular, documented code in Python (and occasionally R) for generating datasets, Tables, Listings, and Figures (TLFs) for regulatory submission.
• Implement software development best practices like version control (Git), automated unit testing, and peer reviews to ensure defect-free outputs.
• Ensure compliance with 21 CFR Part 11, GCP, and internal SOPs for all analytical pipelines and codebases.
• Map DHT data into regulatory-compliant structures such as CDISC SDTM/ADaM standards.

Regulatory Submissions & Documentation:

• Compile final statistical reports, code packages, and validation documents for FDA review.
• Maintain comprehensive audit-ready documentation of data lineage, programming specs, and statistical methodologies.
• Act as statistical SME, communicating complex methods and results to Clinical, Regulatory, and Engineering teams.