Principle Biostatistician

JR United Kingdom; Watford; On-site; GBP 65,000 - 90,000; Full time

Job summary

A leading company in clinical services is seeking a Principal Biostatistician in Watford, Hertfordshire. With over 10 years of experience, you will provide statistical support for clinical studies, engage with regulatory bodies, and lead statistical teams. This position offers the opportunity to work on innovative projects in a multidisciplinary setting, emphasizing teamwork and regulatory compliance.

Qualifications

• 10+ years of experience as a Biostatistician in CRO/Pharma/Biotech.
• Proficiency in SAS, R, or Python.
• Strong knowledge of regulatory guidelines.

Responsibilities

• Provide comprehensive statistical support for clinical studies.
• Engage with regulatory bodies preparing documentation.
• Support Data Monitoring Committees and develop statistical plans.

Skills

Statistical skills

Communication

Leadership

Collaboration

Education

MSc in Biostatistics

PhD in Biostatistics

Tools

SAS

R

Python

Job description

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Principle Biostatistician, Watford, Hertfordshire

Client: AL Solutions

Location: Watford, Hertfordshire, 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 in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions. They support clients to focus on their core strengths. Their experienced team delivers high-touch services and technology for early phase studies through Phase III clinical trials, ensuring safety, ethics, compliance, and innovation across the clinical research community.

Description

The Principal Biostatistician, Clinical Data Systems and Services, 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. Engages with clients and supports sales through expert statistical solutions and SOP development.

Essential Duties and Responsibilities

• Possess a strong understanding of statistical principles and demonstrate strong statistical skills.
• Provide comprehensive statistical support throughout clinical studies.
• Conduct statistical analyses of clinical data and interpret results, focusing on drug safety and study goals.
• Calculate sample sizes, develop study concepts and protocols, create Statistical Analysis Plans (SAP), and prepare clinical study reports, including integrated summaries for regulatory submissions.
• Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and communicating statistical plans and results professionally.
• Support Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock TLFs for interim analysis and reports.
• Implement Clinical Data Interchange Standards Consortium (CDISC) requirements, including SDTM and ADaM datasets creation and quality control.
• Extensive hands-on experience in statistical analysis using SAS, including creating and validating TLFs for NDA and BLA submissions.
• Engage with clients to understand their statistical needs, provide advice, and support sales efforts with proposals and presentations.
• Create and update SOPs related to statistical processes and regulatory submissions.

Education and Experience Required

• 10+ years of experience as a Biostatistician in CRO/Pharma/Biotech.
• 3+ years leading teams of biostatisticians and statistical programmers.
• MSc or PhD in Biostatistics or Statistics.
• Strong communication skills in English, with ability to explain complex concepts.
• Proficiency in SAS, R, or Python.
• Experience with BASE, STAT, MACRO, GRAPH, and database structures.
• Ability to lead and promote teamwork in a multidisciplinary setting.
• Strong knowledge of regulatory guidelines and clinical development methodologies.
• Excellent written and verbal communication skills.
• Ability to mentor new team members.
• Experience in cross-functional collaboration and stakeholder management.