Principle Biostatistician

JR United Kingdom; Bolton; On-site; GBP 60,000 - 95,000; Full time

Job summary

A leading company in the life sciences industry is seeking a Principal Biostatistician to support and analyze clinical studies. This position requires robust statistical expertise and leadership skills, emphasizing client engagement and compliance with regulatory standards. Ideal candidates will have over 10 years of experience in a biostatistical role, with proficiency in SAS and excellent communication abilities.

Qualifications

• Over 10 years of experience as a Biostatistician in CRO/Pharma/Biotech.
• At least 3 years leading biostatistics teams in similar settings.
• Excellent communication skills in English.

Responsibilities

• Apply strong statistical principles to support clinical studies.
• Conduct analyses and interpret results focused on drug safety.
• Engage with regulatory bodies and prepare documentation.

Skills

Statistical principles

Client engagement

Team leadership

Cross-functional collaboration

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Python

Job description

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Client:

AL Solutions

Location:

Bolton, Greater Manchester, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

4

Posted:

26.06.2025

Expiry Date:

10.08.2025

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Job Description:

My client, an emerging leader in clinical services and software solutions for the life sciences industry, is seeking a Principal Biostatistician to join their team. They have expertise across various therapeutic areas and focus on innovative, technology-enabled solutions to support clients in their core strengths. The team delivers high-touch services and technology for early phase studies through Phase III clinical trials, emphasizing ethics, compliance, and innovation.

Role Overview

The Principal Biostatistician will possess robust statistical expertise, supporting and analyzing clinical studies. Responsibilities include study design, reporting, regulatory engagement (FDA, EMEA), and working with CDISC standards. Proficiency in SAS and experience with DMC/DSMB support are essential. The role involves client engagement, providing statistical solutions, and developing SOPs.

Key Responsibilities

• Apply strong statistical principles to support clinical studies
• Conduct analyses and interpret results focusing on drug safety and efficacy
• Calculate sample sizes, develop study protocols, create SAPs, and prepare clinical study reports
• Engage with regulatory bodies, preparing documentation and communicating results
• Support DMC/DSMB activities, including interim analyses and report preparations
• Implement CDISC standards, including SDTM and ADaM datasets
• Perform statistical analyses using SAS, validating TLFs for NDA/BLA submissions
• Engage with clients to understand needs and support sales efforts
• Develop and update SOPs related to statistical processes

Qualifications & Experience

• Over 10 years of experience as a Biostatistician in CRO/Pharma/Biotech
• At least 3 years leading biostatistics teams in similar settings
• MSc or PhD in Biostatistics or Statistics
• Excellent communication skills in English
• Proficiency in SAS, R, or Python; experience with BASE, STAT, MACRO, GRAPH
• Understanding of database structures and TLFs
• Leadership skills to promote teamwork in multidisciplinary environments
• Knowledge of regulatory guidelines and clinical development methodologies
• Mentoring skills for onboarding new team members
• Strong stakeholder management and cross-functional collaboration skills