Overview
As a Senior PK Analyst, you will serve as a subject-matter expert within CPMS, delivering PK/PD parameter derivations and supporting data programming for NONMEM, PK/PD datasets, and summary outputs. You work independently on diverse clinical development projects and mentor colleagues. You will apply ICH-GCP standards, drive process improvements, and collaborate with cross-functional stakeholders to ensure timely, high-quality deliveries. This role offers remote work from listed locations, contributing to Parexel’s mission to improve patient health.
Responsabilità
- Derivation of PK and PD parameters
- Programming and validation of NONMEM datasets and PK/PD derived data
- Programming and validation of tables, listings, figures, and statistical appendices
- Adhere to SOPs and timelines, ensuring quality and alignment with specifications
- Apply good programming practices per ICH-GCP standards
- Lead or participate in process/quality improvement initiatives
- Possibly act as process/system owner in collaboration with IT and Quality
- Provide programming support and mentoring to colleagues
Requisiti fondamentali
- 4–6 years of relevant experience
- Expert knowledge of SAS (BASE, STAT, GRAPH) or R; preference for R
- Experience with Phoenix WinNonlin or equivalent
- Knowledge of pharmacokinetic data
- Advanced skills in Microsoft applications
- Understanding of regulatory industry standards
- Unix/Linux knowledge is advantageous
- Strong communication and project management skills
- Ability to multitask, prioritize, and work under pressure
- Excellent English (written and spoken)
- Professional attitude
- Self-motivation
- Attention to detail
- Pharmacokinetic/pharmacodynamic analysis
- SAS (BASE, STAT, GRAPH) or R (preferably R)
- NONMEM data programming
Senior PK Analyst datore di lavoro: Parexel
La nostra azienda è un datore di lavoro eccezionale, offrendo un ambiente di lavoro stimolante e collaborativo per i professionisti delle affari regolatori nel settore dei dispositivi medici. Con opportunità di crescita professionale e un forte impegno per l'innovazione, i dipendenti possono contribuire attivamente a strategie globali mentre lavorano in diverse località europee, sia da casa che in ufficio. Inoltre, la cultura aziendale promuove il supporto reciproco e il miglioramento continuo, rendendo ogni giorno significativo e gratificante.
