Joshua L.

I help IVD and pharmaceutical companies build reproducible statistical computing environments, automate regulatory outputs, and analyze complex clinical data. With 20+ years spanning commercial biotech and academia, I provide expert biostatistical consulting and R programming tailored to strict industry standards. Services Provided: - IVD Analytical Validation (AV) & TFL Automation: End-to-end generation of audit-ready Tables, Figures, and Listings (TFLs) for IVD regulatory submission packages (510(k)/PMA), process quality control, and assay performance studies. - Custom R Package Engineering: Designing, building, and unit-testing reproducible internal R packages, automated analysis templates, and robust workflow tools (renv, S3/S4). - Statistical Strategy & Analysis Plans: Authoring Statistical Analysis Plans (SAPs), power and sample size analysis, experimental design, and mixed-effects/survival modeling for clinical and pre-clinical research. - Cloud & Open-Source Infrastructure: Containerizing statistical environments (Docker, AWS) and supporting modern open-source analytics platforms, including R/Shiny dashboards and Pharmaverse/TEAL integrations. Skills R (Programming Language) Biostatistics Data Science Statistical Modeling R Shiny CDISC R Package Development Bioinformatics Docker Amazon Web Services (AWS) Analytical Validation (AV) In-Vitro Diagnostics (IVD) Data Pipelines Git Signal Processing I pride myself on clear communication, rapid turnaround, and delivering audit-ready code. Let's discuss how I can support your project.