Job Description
Contract Pharmacokinetics Statistician – Phase I PK Analysis (Zero Hours Contractor)
Location: Remote / Flexible
Contract Type: Zero Hours Specialist Contractor (Time and Materials)
Function: Statistics / Clinical Pharmacology
About the Role
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.
Key Responsibilities
PK Data Analysis and Reporting
- 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
Quality Control and Peer Review
- 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
Protocol and SAP Alignment
- 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
Cross-Functional Collaboration
- 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
Scientific and Knowledge Contribution
- 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
Contract Details
- Flexible zero-hours arrangement based on project demand
- Time and materials engagement model
- Opportunity to support a range of early-phase clinical development programmes
- Fully remote working environment
How to Apply
Please submit your CV outlining relevant PK analysis experience and availability for contract work.
About You
Qualifications and Knowledge
- 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
Experience
- 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
Technical Skills
- 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
