Statistician - Pharmacokinetics Job at Quanticate

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

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Statistician - Pharmacokinetics

Job Description

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