Zero - Statistician - Pharmacokinetics; PK

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

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.

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

• 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

Please submit your CV outlining relevant PK analysis experience and availability for contract work.

• 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 Win Nonlin is beneficial but not essential
• Strong analytical accuracy and attention to detail
• Ability to work independently while adhering to defined specifications