Services rendered will adhere to applicable client 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 andQC 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.
