Job Description
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).
• 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).
Apply for this Position
Ready to join Cytel? Click the button below to submit your application.
Submit Application