Zero - Statistician - Pharmacokinetics; PK

Position: Zero Hour Contract - 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 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. Requirements 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 Win Nonlin is beneficial but not essential • Strong analytical accuracy and attention to detail • Ability to work independently while adhering to defined specifications #J-18808-Ljbffr