Principle Biostatistician

JR United Kingdom; Portsmouth; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in clinical services is seeking a Principal Biostatistician to support their team in delivering innovative solutions for clinical trials. The candidate will utilize robust statistical skills, engage with regulatory bodies, and drive compliance in clinical research effectively. With a focus on leadership and collaboration, this role aims to enhance statistical processes and ensure the highest standards of regulatory adherence, making a significant impact on the quality and success of clinical studies.

Qualifications

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

Responsibilities

• Provide statistical support throughout clinical studies.
• Conduct analyses and prepare reports for regulatory submissions.
• Engage with FDA and EMEA, prepare statistical documents.

Skills

Statistical analysis

Communication

Team leadership

SAS programming

Statistical interpretation

Project management

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Python

Job description

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Client:

AL Solutions

Location:

portsmouth, hampshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

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 looking for a Principal Biostatistician to join their team. With 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. For early phase studies through Phase III clinical trials, their experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

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. Actively engage with clients and support 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 the results, focusing on the efficiency and safety of drug molecules or study goals
• Experienced in calculating sample sizes, developing concepts and protocols for studies, creating Statistical Analysis Plans (SAP), and preparing clinical study reports, including integrated summaries for regulatory submissions
• Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and effectively communicating statistical plans and results in professional forums.
• Provide support for Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB support. This encompasses interim analysis, TLF shells, both blinded and unblinded reports, and organizing kick-off meetings
• Solid understanding and implementation of Clinical Data Interchange Standards Consortium (CDISC) requirements for regulatory submissions, including experience with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications generation and quality control of datasets
• Extensive hands-on experience in statistical analysis using SAS, including creating mock shells for tables, listings, and figures (TLFs), and validating TLFs for New Drug Applications (NDA) and Biologics License Applications (BLA) submissions
• Actively engage with clients to understand their statistical and analytical needs, providing expert advice and solutions. Support the sales cycle by contributing to proposals, presentations, and discussions that showcase our statistical capabilities and how they meet client requirements
• Responsible for the creation and updating of Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions

EDUCATION AND EXPERIENCE REQUIRED

• 10+ years of experience as a Biostatistician and working in a CRO/Pharma/Biotech company
• 3+ years of experience in leading a team of biostatisticians and statistical programmers in a CRO/Pharma/Biotech setting
• MSc or PhD in Biostatistics or Statistics
• Strong written and verbal communication skills in English, with the ability to explain complex statistical concepts to non-statisticians
• Proficient in statistical programming languages such as SAS, R, or Python
• Proficient in BASE, STAT, MACRO, and GRAPH procedures, with understanding of database structures and TLF generation
• Capable of leading and promoting teamwork in a multidisciplinary environment
• Strong knowledge of regulatory guidelines and statistical methodologies related to clinical development
• Excellent communication skills, both written and verbal
• Experience coaching and mentoring new team members for efficient onboarding
• Ability to collaborate across functions and manage stakeholders effectively