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 WinNonlin is beneficial but not essential Strong analytical accuracy and attention to detail Ability to work independently while adhering to defined specifications #J-18808-Ljbffr QUANTICATE INTERNATIONAL LIMITED