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
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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
Apply tot his job
Apply To this Job