14 set - Bardi
Parexel
OverviewAs 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.
ResponsabilitàDerivation 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 fondamentali4–6 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
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