Sr Clinical Shiny Developer

Mission:
Advance precision genetic medicines for rare diseases through modern analytics, interactive applications, and validated, reusable clinical modules.
Job Description:
We're evolving how trials are monitored, analyzed, and read out moving beyond static TFLs to dynamic, validated applications and modular workflows. You'll help build and scale custom analytical apps for study readouts and SRCs and contribute to our R + AI modernization across Posit Workbench/Connect and fit-for-purpose validation.
What You'll Build And Own:

• Study readout & SRC applications:
  Lead the design and delivery of interactive Shiny applications used in pre-readouts, regulator prep, and Safety Review Committee workflows.
• Reusable clinical modules & review apps:
  Engineer reusable modules and codify patterns that enable portfolio-wide reuse, validation, and efficient ongoing clinical review.
• Technical R + AI transformation:
  Drive the SMART transformation: qualified Posit environments, HPCE for simulations, Copilot/LLM-assisted workflows, and best-practice SOPs/WIs for AI and R usage.

• Translate clinical questions into interactive analyses and visuals that accelerate decision-making at readouts and SRCs.
• Architect modular, testable Shiny applications and packages with CI/CD, staged dependencies, and secure data mounts for Connect deployments.
• Champion R + AI adoption (Copilot, LLM prototypes, Positron) to reduce manual effort and improve reproducibility.
• Mentor cross-functional teams and external partners on IDEA-R tooling, reusable modules, and readout best practices.

• We are not filling three separate titles we're seeking individuals who bring one (or, ideally, a blend) of these core skill sets.
• Clinical Storyteller.
• End-to-end trial leadership, estimands, FDA/EMA submission writing; deep R for visuals/Shiny; turning clinical questions into executable R + compelling narratives.
• Full-Stack Data Scientist.
• Shiny engineering at production quality, infrastructure (Posit Connect/Workbench, Linux/HPC), and Python/LLM integration.
• Bilingual Programmer (SAS ? R).
• SAS mastery + modern R; pharmaverse/admiral pipelines; risk-based validation in GxP; R for submissions and SOP development in SAS-centric orgs. CDISC pipelines (SDTM/ADaM).

• Demonstrated delivery of interactive clinical apps used in clinical research setting.
• Hands-on R/Shiny and CDISC fluency (SDTM/ADaM) for analysis and visualization.
• Ability to communicate findings to clinicians and leadership linking interactive outputs to regulatory narratives.

• Exposure to GenAI/LLM in clinical workflows; interest in Positron.
• Pharma verse contributions or leadership in reusable clinical modules.