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Statistical Programmer

Warman O'Brien

Senior PK/PD Programmer | FSP | Leading CRO / Top Pharma | Home Based | UK & Europe | An exciting opportunity to join a leading global CRO within a sponsor-dedicated FSP model, working exclusively with a top pharma. We are looking for an experienced Senior PK/PD Programmer to support a global Pharmacometrics team within Clinical Pharmacology & Pharmacometrics. This specialist position will focus on the programming and QC of high-quality PK/PD NONMEM datasets, alongside R programming and supporting Pharmacometrics activities. You will work closely with Pharmacometrics, Data Management, Statistical Programming and Bioanalytical teams. Previous PK/PD experience is essential for this role, and interviews are taking place immediately. What you will be doing: Program and QC NONMEM PK/PD datasets based on SDTM and ADaM datasets. Deliver accurate, complete and high-quality NONMEM input data within agreed timelines. Work with datasets both before and after database lock. Perform QC of outsourced NONMEM datasets. Support the preparation of Pharmacometrics projects for regulatory submissions. QC customised R packages used to standardise Pharmacometrics activities. Review programming requirements and data, identify gaps and recommend solutions. Contribute to Pharmacometrics programming standards and process improvements. Collaborate with Clinical Pharmacology, Data Management, Statistics, Statistical Programming teams. What you will need: Previous PK/PD | Pharmacokinetics experience is essential. Strong R programming experience. Experience programming and/or QCing NONMEM datasets. Good knowledge of PK/PD principles and clinical trial concepts. Knowledge of SDTM, ADaM and controlled terminology. Previous experience with NONMEM file creation, standardisation, submissions and QC. 4+ years of relevant pharmaceutical, biotech or CRO industry experience Degree in a health, science, IT or related discipline. Excellent attention to detail and strong communication skills. What’s in it for you: Opportunity to work within a dedicated FSP model for a top pharmaceutical company. Specialist position within a global Pharmacometrics environment. Fully home-based across Europe. Excellent long-term career development and progression opportunities. Opportunity to work closely with experienced global Clinical Pharmacology and Pharmacometrics teams. #J-18808-Ljbffr

Vacancy posted 4 days ago
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