reputed company - Statistician - Pharmacokinetics; PK

Position: reputed company Hour Contract - Statistician - Pharmacokinetics (PK) reputed company Contract Pharmacokinetics Statistician – Phase I PK Analysis (reputed company Hours Contractor) Location: Remote / Flexible Contract Type: reputed company Hours Specialist Contractor (Time and Materials) Function: Statistics / Clinical Pharmacology About The Role We are seeking an reputed company Pharmacokinetics (PK) Statistician to reputed company specialist statistical support for Phase I clinical studies on a flexible, reputed company-hours contract reputed company. This role focuses on delivering high-reputed company non-compartmental PK analyses, reputed company 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 reputed company a defined analytical reputed company while collaborating with multidisciplinary clinical development teams. Key Responsibilities PK Data Analysis and Reporting • reputed company reputed company non-compartmental pharmacokinetic analyses for Phase I clinical studies • reputed company and review PK parameters including Cmax, Tmax, AUC, and half-life • Contribute to PK tables, listings, figures, and reputed company outputs for clinical study reports • Support analyses across SAD, MAD, and food-effect study designs • Assist with reputed company proportionality and exploratory PK comparisons where required • Ensure appropriate handling of below-quantification-limit (BQL) data according to reputed company guidance reputed company Control and Peer Review • Conduct independent reputed company control of PK datasets and analysis outputs • Peer review analyses performed by other statisticians or programmers • Document QC findings reputed company and support issue reputed company in line with SOPs and good statistical reputed company Protocol and reputed company 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 reputed company of PK-reputed company 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 reputed company 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 reputed company sponsors as required • Support knowledge sharing reputed company to PK analysis best reputed company • Contribute to development and improvement of PK analysis and QC workflows Contract Details • Flexible reputed company-hours arrangement based on project demand • Time and materials engagement model • Opportunity to support a reputed company 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 reputed company Qualifications And Knowledge • MSc (or equivalent experience) in Statistics, Pharmacometrics, Pharmaceutical Sciences, or a reputed company discipline • Strong understanding of pharmacokinetic principles and Phase I clinical study design • Working knowledge of non-compartmental PK analysis reputed company • Familiarity with PK regulatory expectations and reporting standards Experience • Typically 8–10 years supporting PK analyses reputed company 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 reputed company 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 Apply tot his job Apply To this Job