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Zero Hour Contract - Statistician - Pharmacokinetics (PK)

3 months, 2 weeks ago
United Kingdom
Contract
Lead
Data Scientist
Data Science and Analytics
R Statistics
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Quanticate

Quanticate

Quanticate is a leading global Clinical Research Organization (CRO) that specializes in the management, analysis, and reporting of clinical trial data, offering comprehensive services such as statistical analysis, data capture, and pharmacovigilance to...

Health Care Providers & Services
251-1K
Founded 1994
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Description

  • Perform non-compartmental pharmacokinetic analyses for Phase I clinical studies.
  • Generate and review PK parameters including Cmax, Tmax, AUC, and half-life.
  • Prepare PK tables, listings, figures, and summary outputs for clinical study reports.
  • Support analyses for SAD, MAD, and food-effect study designs.
  • Assist with dose proportionality and exploratory PK comparisons when required.
  • Ensure appropriate handling of below-quantification-limit (BQL) data in line with SAP guidance.
  • Conduct independent quality control of PK datasets and analysis outputs.
  • Peer review analyses performed by other statisticians or programmers.
  • Review PK components of protocols and SAPs for feasibility and consistency.
  • Support cross-functional collaboration with bioanalytical, clinical pharmacology, clinical operations, biometrics, programmers, statisticians, and medical writers.

Requirements

  • MSc or equivalent experience in Statistics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline.
  • Strong understanding of pharmacokinetic principles and Phase I clinical study design.
  • Working knowledge of non-compartmental PK analysis methods.
  • Familiarity with PK regulatory expectations and reporting standards.
  • Typically 8–10 years of experience supporting PK analyses in pharmaceutical, biotechnology, or CRO environments.
  • Demonstrated experience analyzing Phase I PK data and contributing to reporting.
  • Proven experience performing QC and peer review of PK outputs.
  • Experience working in consultancy or contract-based delivery models is advantageous.
  • Proficiency in SAS and/or R for PK analysis.
  • Experience with PK software such as Phoenix WinNonlin is beneficial but not essential.

Benefits

  • Flexible zero-hours contractor arrangement based on project demand.
  • Time and materials engagement model.
  • Fully remote working environment.
  • Opportunity to support a range of early-phase clinical development programmes.

Interested in this position?

Apply directly on the company website

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