# Zero Hour Contract - Statistician - Pharmacokinetics (PK)

**Company:** [Quanticate](http://jobs.workable.com/companies/i2x94yqqk4sxTNQaZMnKDJ.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Contract
**Department:** Statistics

[Apply for this job](http://jobs.workable.com/view/a6410550-4482-4120-be2c-bb6bac8ae5f1)

## 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