Principle Biostatistician

JR United Kingdom; Plymouth; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading company in the life sciences industry is seeking a Principal Biostatistician to provide expertise in clinical studies. With a focus on statistical analysis, regulatory compliance, and client engagement, this role demands over 10 years of experience in a CRO/Pharma/Biotech setting.

Qualifications

• 10+ years of experience as a Biostatistician.
• 3+ years in a leadership role in a CRO/Pharma/Biotech environment.
• Strong knowledge of regulatory guidelines.

Responsibilities

• Provide statistical support throughout clinical studies.
• Conduct analyses and interpret statistical results.
• Create and update SOPs related to statistical processes.

Skills

Statistical expertise

Statistical analysis

Sampling

Regulatory compliance

Client engagement

Team leadership

Cross-functional collaboration

Communication

Education

MSc or PhD in Biostatistics or Statistics

Tools

SAS

R

Python

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 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, regulatory engagement (including FDA and EMEA communications), 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 study concepts and protocols, 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. 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, interim analysis, TLF shells, and both blinded and unblinded reports.
7. Implement Clinical Data Interchange Standards Consortium (CDISC) requirements for regulatory submissions, including experience with SDTM and ADaM specifications, dataset generation, and quality control.
8. Extensive hands-on experience in statistical analysis using SAS, including creating 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 with proposals, presentations, and discussions showcasing statistical capabilities.
10. Responsible for creating and updating SOPs related to statistical processes and regulatory submissions.

EDUCATION AND EXPERIENCE REQUIRED

• 10+ years of experience as a Biostatistician in a CRO/Pharma/Biotech setting.
• 3+ years leading a team of biostatisticians and statistical programmers in a CRO/Pharma/Biotech environment.
• MSc or PhD in Biostatistics or Statistics.
• Strong communication skills in English, with the ability to explain complex statistical concepts to non-statisticians.
• Proficiency in statistical programming languages such as SAS, R, or Python.
• Proficiency in BASE, STAT, MACRO, and GRAPH, with understanding of database structures and TLFs.
• Ability to lead and promote teamwork in a multidisciplinary environment.
• Strong knowledge of regulatory guidelines and statistical methodology in clinical development.
• Excellent written and verbal communication skills.
• Experience coaching and mentoring new team members for efficient onboarding.
• Cross-functional collaboration and stakeholder management skills.