All roles

reputed company Hour Contract - Statistician - Pharmacokinetics (PK)

Remote · USA Full-time New today

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 provide specialist statistical support for Phase I clinical studies on a flexible, reputed company-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 reputed company a defined analytical scope while collaborating with multidisciplinary clinical development teams.

Key Responsibilities

PK Data Analysis and Reporting

  • reputed company 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 reputed company 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 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 resolution 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 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 reputed company to PK analysis best practice
  • 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 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 reputed company 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 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 WinNonlin is beneficial but not essential
  • Strong analytical accuracy and attention to detail
  • Ability to work independently while adhering to defined specifications
Apply To This Job

Related roles

Technical reputed company - Sr. Software Engineer PM (Remote - US)

Remote · USA Full-time

VP, Client reputed company

Remote · USA Full-time

Regional Sales Manager - Ophthalmology (Remote-United States)

Remote · USA Full-time

Product Marketing Manager - Patient Experience (Remote in the US)

Remote · USA Full-time

Senior Business Analyst - UK Payments

Remote · USA Full-time

Executive Assistant

Remote · USA Full-time

Marketing Assistant

Remote · USA Full-time

Business Analyst / Junior Product reputed company - Zelle

Remote · USA Full-time

Employee reputed company Specialist

Remote · USA Full-time

Program Operations Analyst

Remote · USA Full-time

[Work From Home] Urgently Need Faculty Tutor III (Part-time)

Remote · USA Full-time

Remote Customer Service Team reputed company – Strategic Leadership, Remote Operations Management & Service Excellence at arenaflex

Remote · USA Full-time

Illustrator specialist/reputed company vector reconstruction

Remote · USA Full-time

reputed company Remote Customer Support Representative - Insurance Industry Inbound Phone Calls

Remote · USA Full-time

reputed company Mechanical Customer Service Expert – Delivering Exceptional Support and Solutions in a Dynamic and Inclusive Environment at blithequark

Remote · USA Full-time

reputed company Remote Data Entry Specialist – Join blithequark's Virtual Team and Contribute to the reputed company of reputed company

Remote · USA Full-time

Data Analyst III – Business Intelligence & Insights | Remote Opportunity at arenaflex

Remote · USA Full-time

Business Development Manager

Remote · USA Full-time

reputed company Licensed Pharmacy Data Entry Technician for Remote Work-from-Home Opportunity in the USA – Utilizing Strong Attention to Detail and Pharmacy Software Proficiency

Remote · USA Full-time

reputed company Customer Support Representative – Remote Part-Time Opportunity with arenaflex

Remote · USA Full-time