Modeling&SimulationsScientistII-PKPDProgramming

**Job Description** **General Summary:** The Modeling & Simulations Scientist II-(PKPD Programming) is a primarily hands-on programming leader responsible for delivering high-quality PK/PD, PopPK, and exposure-response analysis datasets, outputs, and regulatory submission deliverables, while advancing process standardization, automation, and quality across Phase 1–3 studies. This role also provides team and operational management through resource planning, mentoring, workload coordination, and oversight of programming activities to ensure timely, compliant, and efficient delivery. By combining technical expertise with people leadership, the position supports Clinical and Quantitative Pharmacology objectives and contributes to the successful execution of the development portfolio. **Key Duties and Responsibilities:** * **Lead hands-on PK/PD programming deliverables** by creating, validating, and delivering analysis-ready datasets, outputs, and supporting files for Population PK, PK/PD, and exposure-response analyses, ensuring high-quality and timely support for clinical pharmacology objectives. * **Drive programming quality, consistency, and process standardization** across studies by establishing, refining, and implementing repeatable workflows, specifications, QC practices, and programming standards to improve efficiency, reduce risk, and support inspection readiness. * **Provide technical oversight and quality control of analysis datasets and data manipulation** by reviewing programming methods, validating derived datasets, and ensuring outputs used by analysts are accurate, traceable, and fit for purpose. * **Develop and maintain automated programming solutions** for Phase 1–3 studies to streamline dataset generation, reporting, and submission preparation, thereby optimizing timelines and increasing operational scalability. * **Support regulatory and clinical study reporting deliverables** by managing submission-ready packages, including datasets, scripts, model