Principle Biostatistician

JR United Kingdom; Kingston upon Hull; On-site; GBP 70,000 - 100,000; Full time

Job summary

A global leader in clinical services is seeking a Principal Biostatistician in Kingston upon Hull to provide expertise for clinical studies. The role involves strong statistical analysis, regulatory engagement, team leadership, and the use of SAS for ensuring compliance and support in study designs. Ideal candidates should possess over 10 years of experience and a master's or doctoral degree in relevant fields.

Qualifications

• 10+ years as a Biostatistician in CRO/Pharma/Biotech.
• 3+ years leading a team of biostatisticians.
• Experience with regulatory guidelines.

Responsibilities

• Conduct analyses of clinical data focusing on drug safety.
• Engage with regulatory bodies for statistical documentation.
• Support clinical studies and lead DMC/DSMB activities.

Skills

Statistical expertise

SAS proficiency

Statistical methodology knowledge

Strong communication skills

Team leadership

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Python

Job description

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Principle Biostatistician, Kingston upon Hull, East Yorkshire

Client:

AL Solutions

Location:

Kingston upon Hull, East Yorkshire, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

4

Posted:

26.06.2025

Expiry Date:

10.08.2025

Job Description:

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

Description

The Principal Biostatistician should possess robust statistical expertise, providing comprehensive support and analysis for clinical studies. Skilled in study design, reporting, and regulatory engagement, including FDA and EMEA communications. Experienced with CDISC standards, SAS proficiency, and DMC/DSMB support. Actively engage with clients and support sales through expert statistical solutions and SOP development.

Essential Duties and Responsibilities

• Understand statistical principles and demonstrate strong statistical skills.
• Provide support throughout clinical studies.
• Conduct analyses of clinical data, focusing on drug safety and efficacy.
• Calculate sample sizes, develop study concepts and protocols, create SAPs, and prepare clinical study reports for regulatory submissions.
• Engage with regulatory bodies, preparing statistical documentation and communicating plans and results.
• Support DMC/DSMB activities, including charter development, interim analysis, and report organization.
• Implement CDISC requirements, including SDTM and ADaM datasets.
• Use SAS for statistical analysis, creating TLFs, and validating submissions.
• Engage with clients to understand needs and support proposals and presentations.
• Maintain and update SOPs related to statistical processes.

Education and Experience Required

• 10+ years of experience as a Biostatistician in CRO/Pharma/Biotech.
• 3+ years leading a team of biostatisticians and programmers.
• MSc or PhD in Biostatistics or Statistics.
• Strong communication skills in English.
• Proficient in SAS, R, or Python.
• Experience with BASE, STAT, MACRO, GRAPH, and database structures.
• Ability to lead and promote teamwork.
• Knowledge of regulatory guidelines and statistical methodology.
• Mentor and support team onboarding.
• Strong stakeholder management skills.