Quanticate
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Quanticate is a leading global biometric Contract Research Organisation (CRO) specializing in clinical data analysis for the pharma and biotech industries. They provide a range of services focused on enhancing clinical trial efficiency and success, including biostatistics, clinical data management, medical writing, and pharmacovigilance. Quanticate leverages advanced methodologies, such as Bayesian approaches, to optimize trial execution and data standardization, ensuring compliance with regulatory standards. They offer scalable resources tailored to client needs and have expertise across various therapeutic areas and trial phases, from early Phase I to post-marketing Phase IV trials. Quanticate is known for its robust data automation, visualisation, and analytics capabilities, which support decision-making and regulatory submissions.
Statistician – Pharmacokinetics (PK)
🔥 0 minutes ago
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Quanticate
201 - 500 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Quanticate is a leading global biometric Contract Research Organisation (CRO) specializing in clinical data analysis for the pharma and biotech industries. They provide a range of services focused on enhancing clinical trial efficiency and success, including biostatistics, clinical data management, medical writing, and pharmacovigilance. Quanticate leverages advanced methodologies, such as Bayesian approaches, to optimize trial execution and data standardization, ensuring compliance with regulatory standards. They offer scalable resources tailored to client needs and have expertise across various therapeutic areas and trial phases, from early Phase I to post-marketing Phase IV trials. Quanticate is known for its robust data automation, visualisation, and analytics capabilities, which support decision-making and regulatory submissions.
📋 Description
• 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 • 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 • 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 • 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 • 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
🎯 Requirements
• 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 WinNonlin is beneficial but not essential • Strong analytical accuracy and attention to detail • Ability to work independently while adhering to defined specifications
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