At a Glance
- Tasks: Conduct Phase I PK analyses and collaborate with clinical teams on exciting projects.
- Company: Join a leading firm in clinical pharmacology with a flexible work culture.
- Benefits: Enjoy a fully remote role with a zero-hours contract tailored to your availability.
- Other info: Perfect for independent thinkers looking for dynamic project-based work.
- Why this job: Make a real impact in early-phase clinical studies while honing your statistical skills.
- Qualifications: MSc in Statistics or related field, with strong PK analysis experience.
The predicted salary is between 63000 - 77000 £ per year.
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
Job Summary
ID: 72DE358E36
Department: Statistics
Type: contract time
Zero Hour Contract - Statistician - Pharmacokinetics (PK) in Moffat employer: Quanticate
Quanticate is an exceptional employer that values innovation and collaboration, particularly in the dynamic field of Life Sciences. With a strong focus on employee growth, we offer flexible working arrangements and a comprehensive benefits package, ensuring our team members thrive both professionally and personally. Join us to be part of a supportive work culture that encourages creativity and excellence in every proposal we craft.
StudySmarter Expert Advice🤫
We think this is how you could land Zero Hour Contract - Statistician - Pharmacokinetics (PK) in Moffat
✨Network like a Pro
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We think you need these skills to ace Zero Hour Contract - Statistician - Pharmacokinetics (PK) in Moffat
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what Quanticate might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of Quanticate. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at Quanticate
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of Quanticate.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
