Principle Biostatistician

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

Job summary

A leading clinical services and software solution company seeks a Principal Biostatistician to enhance its team. The role entails providing extensive statistical support, engaging with regulatory bodies, and leading teams to fulfill complex clinical study requirements, focusing on innovation and compliance.

Qualifications

• 10+ years in Biostatistics, preferably in CRO/Pharma/Biotech.
• 3+ years leading teams.
• Proficient in SAS, R, or Python.

Responsibilities

• Conduct statistical analyses and provide comprehensive support for clinical studies.
• Engage with regulatory bodies and prepare statistical documentation.
• Support clients and sales with expert statistical solutions.

Skills

Statistical expertise

Communication Skills

Team Leadership

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Python

Job description

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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 a 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

1. Possess a strong understanding of statistical principles and demonstrate strong statistical skills.
2. Provide comprehensive statistical support throughout clinical studies.
3. Conduct statistical analyses of clinical data and interpret the results, focusing on the efficiency and safety of drug molecules or study goals.
4. Experience 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.
5. Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and effectively communicating statistical plans and results in professional forums.
6. Support Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB support. This includes interim analysis, TLF shells, both blinded and unblinded reports, and organizing kick-off meetings.
7. Understand and implement 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.
8. Extensive hands-on experience in statistical analysis using SAS, including creating mock shells for tables, listings, and figures (TLFs), and validating TLFs for NDA and BLA submissions.
9. 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 statistical capabilities and how they meet client requirements.
10. Responsible for creating and updating Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.

EDUCATION AND EXPERIENCE REQUIRED

• 10+ years of experience as a Biostatistician, working in a CRO/Pharma/Biotech company.
• 3+ years of experience leading teams of biostatisticians and statistical programmers in a CRO/Pharma/Biotech setting.
• MSc or PhD in Biostatistics or Statistics.
• Strong written and verbal communication skills, including proficiency in English and 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, with an understanding of database structures and TLFs.
• Capable of directing and promoting teamwork in a multidisciplinary environment.
• Strong knowledge of regulatory guidelines and statistical methodology related to clinical development.
• Excellent written and verbal communication skills.
• Ability to coach and mentor new team members for efficient onboarding.
• Experience in cross-functional collaboration and stakeholder management.