Deliverables:
• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Clear communication with partnering departments: Data Management, Statistics, Statistical Programming and Bio-analytical providers.
• Ensures quality NONMEM input data (accurate, valid and complete) is provided to the Pharmacometrics Leaders within projected timelines for low to medium complexity projects.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• Programming and QC of NONMEM PK/PD datasets based on SDTM/ADAM datasets.
• Follow up and QC of outsourced NONMEM datasets.
• Prepare submission projects per internal PM guideline.
• QC of existing, customized R packages used for standardization of Pharmacometric works (build testing suite of customized packages).
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