PK Scientist
ICON plc
3 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
IntermediateJob location
Remote
Tech stack
Data Structures
WinNonlin Software
Data Processing
Data Management
Job description
- Author and coordinate development of clinical pharmacology trial protocols and ensure timely review, approval, and issuance.
- Perform preliminary, interim, and final PK, PD, and PK/PD analyses using non-compartmental methods.
- Develop the Clinical Pharmacology Analysis Plan (CPAP) and generate data handling logbooks prior to final NCA.
- Create tables, listings, and figures and contribute to drafting clinical pharmacology sections of Clinical Study Reports (CSRs).
- Conduct QC review of protocols, analyses, datasets, and all deliverables while ensuring compliance with SOPs, ICH-GCP, and regulatory requirements.
Requirements
- Bachelor's degree or higher in a scientific discipline (or equivalent experience) with strong written and verbal communication skills.
- Hands-on experience with Phoenix WinNonlin and working knowledge of R for PK/PD analysis ( Experience with R is an advantage ).
- Experience performing non-compartmental pharmacokinetic analysis (NCA) and interpreting PK/PD data.
- Understanding of clinical trial data structures and experience collaborating with Data Management, Biostatistics, and CRO partners.
- 4+ years of relevant experience in clinical pharmacology, including exposure to clinical study protocols and regulatory requirements.
Benefits & conditions
What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
About the company
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.