Pharmacometrics Support Scientist
Johnson & Johnson Innovative Medicine · Nandigama
Job description
About the role
The Pharmacometrics Support Scientist provides technical assistance to the Clinical Pharmacology & Pharmacometrics (CPP) team, focusing on automating routine deliverables and improving operational efficiency. The role ensures timely, high‑quality data assembly, quality control, and documentation for regulatory submissions.
Key responsibilities
- Standardize R scripts and functions to generate ADNCA and NONMEM input datasets from SDTM, ADaM, or other source formats, leveraging GenAI tools.
- Create default routines for variable definition documentation to support submission packages.
- Perform basic Pharmacometrics quality‑control activities on AI‑generated code, documenting findings and follow‑up actions.
- Suggest and implement process improvements, including automation and standardization of scripts and tools.
- Support updates to SOPs, job aids, templates, and training materials as needed.
- Follow CPP processes, SOPs, and regulatory instructions.
Required profile
- Bachelor’s degree (or equivalent) in a scientific discipline.
- 1‑2 years of experience in the pharmaceutical industry, preferably in Clinical Pharmacology, Pharmacometrics, or data‑analysis support.
- Familiarity with CPP processes and regulatory expectations.
Required skills
- Proficiency in R for data manipulation.
- Basic knowledge of SDTM and ADaM data standards.
- Experience with NONMEM input dataset preparation.
- Exposure to GenAI or AI‑enabled automation tools.
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Published 1 month ago
Expires 2 weeks from now
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Johnson & Johnson Innovative Medicine
Nandigama
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