Pharmacometrics Programmer

Role & responsibilities

The Pharmacometrics (PM) Support Programmer provides support to the global Pharmacometrics modelling team within Clinical Pharmacology & Pharmacometrics in delivering high quality PK/PD NONMEM datasets. Services also include quality control of the NONMEM datasets, and QC of customized R packages created for the department. Datasets are created both before (unclean data) and after database lock. This function liaises closely with Data Management, Statistical Programming, and bio-analytical teams. Services are delivered by applying efficient R programming skills and knowledge of basic PK/PD concepts.

Deliverables:

• 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 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).

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. 3+ 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.