Pharmacometrics (PM) Support Programmer
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• Services rendered will adhere to applicable client SOPs,WIs, policies, localregulatoryrequirements,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 Pharmacometrics works (build testing suite of customized packages).
• Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
• Critically reviews requirements and data, identifies gaps, suggests solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Involved as active driver in development of new PM standardization efforts. Education And Experience Requirements/Qualifications
• Minimum degree: BA/BS
• Degree in a health or science related field. IT degree can also be considered if working knowledge with R software.
• Min. 4 to 10 years industry experience.
• Strong working knowledge of R software (important)
• Interest in PK/PD and clinical trial concepts.
• Studious and data driven person. Eye for detail is very important.
• Proficient in speaking and writing in English. Effective communication skills, oral and written. This job is provided by Shine.com
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