Principal Statistician (Pharmacokinetics)

TL;DR

Principal Statistician (Pharmacokinetics): Leading statistical activities for global clinical trials with an accent on PK analysis, CDISC ADaM standards, and regulatory compliance. Focus on providing expert statistical strategy, managing project-level teams, and ensuring high-quality deliverables for complex clinical research programs.

Location: Oxford, UK

Company

A dynamic, global clinical research organization founded in 1995, dedicated to changing lives through medical science with a team of over 2,700 professionals.

What you will do

• Act as the primary communication lead for project teams, clients, and vendors regarding statistical inquiries.
• Conduct comprehensive statistical analyses for clinical trials, including interim, final, DSMB/DMC, and PK analyses.
• Develop and review study protocols, statistical analysis plans, and ADaM dataset specifications.
• Lead and mentor teams of SAS programmers and statisticians at the project level.
• Provide expert input on standard operating procedures and quality system documents.
• Prepare for and participate in internal and external study audits.

Requirements

• MSc in Statistics or an equivalent degree.
• Full working proficiency in English.
• Expert knowledge of statistical principles, clinical research standards, and SAS programming.
• Deep understanding of CDISC ADaM standards and pharmacokinetics principles (NCL and population PK).
• Proficiency in Phoenix WinNonlin and NLME software.
• Strong familiarity with FDA, EMA, and ICH regulatory guidelines.

Culture & Benefits

• Work within a global, collaborative environment focused on medical science and patient impact.
• Opportunity to lead international teams and influence statistical strategy.
• Commitment to staff development through induction courses and project-specific training.
• Supportive culture focused on quality and professional dedication.