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Statistician - Pharmacokinetics

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Quanticate

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Location:
United Kingdom

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Contract Pharmacokinetics Statistician – Phase I PK Analysis (Zero Hours Contractor). We are seeking an experienced Pharmacokinetics (PK) Statistician to provide specialist statistical support for Phase I clinical studies on a flexible, zero-hours contract basis. This role focuses on delivering high-quality non-compartmental PK analyses, quality control activities, and analytical peer review in line with study protocols, Statistical Analysis Plans (SAPs), and regulatory expectations. This is an ideal opportunity for a contractor who enjoys working independently within a defined analytical scope while collaborating with multidisciplinary clinical development teams.

Job Responsibility:

  • Perform standard non-compartmental pharmacokinetic analyses for Phase I clinical studies
  • Generate and review PK parameters including Cmax, Tmax, AUC, and half-life
  • Contribute to PK tables, listings, figures, and summary outputs for clinical study reports
  • Support analyses across SAD, MAD, and food-effect study designs
  • Assist with dose proportionality and exploratory PK comparisons where required
  • Ensure appropriate handling of below-quantification-limit (BQL) data according to SAP guidance
  • Conduct independent quality control of PK datasets and analysis outputs
  • Peer review analyses performed by other statisticians or programmers
  • Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice
  • Review PK components of protocols and SAPs to confirm feasibility and internal consistency
  • Ensure analyses are performed according to specifications and document any assumptions or deviations
  • Support resolution of PK-related analytical queries
  • Work closely with bioanalytical, clinical pharmacology, clinical operations, and biometrics teams
  • Support integration of PK outputs into clinical study reports alongside safety and tolerability data
  • Liaise with programmers, statisticians, and medical writers to ensure traceability and consistency of deliverables
  • Participate in scientific discussions with internal teams and external sponsors as required
  • Support knowledge sharing related to PK analysis best practice
  • Contribute to development and improvement of PK analysis and QC workflows

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 supporting PK analyses within pharmaceutical, biotechnology, or CRO environments
  • Demonstrated experience analysing 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
  • Familiarity with PK software such as Phoenix WinNonlin is beneficial but not essential
  • Strong analytical accuracy and attention to detail
  • Ability to work independently while adhering to defined specifications

Nice to have:

  • Familiarity with PK software such as Phoenix WinNonlin
  • Experience working in consultancy or contract-based delivery models

Additional Information:

Job Posted:
February 16, 2026

Work Type:
Remote work
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