About the Company
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to accelerating clinical development and commercialization, enabling our clients to improve human health. With a presence in over 100 countries, IQVIA combines unparalleled data, advanced analytics, and domain expertise to help clients drive healthcare forward.
Job Description
We are seeking a highly motivated and detail-oriented Pharmacokinetic Analyst with a strong focus on clinical data to join our dynamic team. This role is crucial for analyzing pharmacokinetic (PK) data from clinical trials, supporting drug development programs, and contributing to regulatory submissions. The successful candidate will leverage their expertise in PK analysis software and statistical methodologies to interpret complex datasets and provide actionable insights. This position offers the flexibility of remote work, allowing you to contribute to cutting-edge research from anywhere.
Key Responsibilities
- Perform non-compartmental and compartmental pharmacokinetic analysis of clinical trial data.
- Develop, validate, and implement PK analysis methods using specialized software (e.g., WinNonlin, Phoenix NLME).
- Interpret PK data, identify trends, and generate comprehensive reports for internal and external stakeholders.
- Collaborate with clinical pharmacology, biostatistics, and data management teams to ensure data quality and integrity.
- Contribute to the preparation of clinical study reports, regulatory documents, and scientific presentations.
- Stay abreast of industry best practices, regulatory guidelines, and new technologies in pharmacokinetic analysis.
- Participate in study design discussions, providing input on PK sampling schedules and analysis plans.
Required Skills
- Proficiency in PK analysis software (e.g., WinNonlin, Phoenix WinNonlin).
- Strong understanding of pharmacokinetic principles and methodologies.
- Experience with clinical trial data and regulatory submission processes.
- Excellent analytical and problem-solving skills.
- Ability to interpret and communicate complex scientific data effectively.
- Proficiency in statistical software (e.g., R, SAS) for data manipulation and visualization.
Preferred Qualifications
- Master's or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, or a related field.
- Experience with population PK modeling using Phoenix NLME or similar software.
- Familiarity with CDISC standards (SDTM, ADaM) for clinical data.
- Prior experience working in a CRO or pharmaceutical industry setting.
- Knowledge of relevant FDA, EMA, and ICH guidelines.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- 401(k) retirement plan with company match.
- Life and disability insurance.
- Professional development and continuing education opportunities.
- Employee assistance program.
- Flexible work arrangements and a strong remote work culture.
- Wellness programs and resources.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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