Principle Biostatistician

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

Job summary

A leading company in Clinical services seeks a Principal Biostatistician to support clinical studies and regulatory engagement. The role requires extensive experience in statistical analysis and team leadership within the life sciences industry, focusing on innovative solutions and compliance with industry standards.

Qualifications

• 10+ years of experience in a CRO/Pharma/Biotech setting.
• Experience leading teams of biostatisticians.
• Strong communicative ability to explain statistical concepts.

Responsibilities

• Provide comprehensive statistical support for clinical studies.
• Engage with regulatory bodies such as FDA and EMEA.
• Implement CDISC requirements for regulatory submissions.

Skills

Statistical expertise

SAS

Statistical analysis

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 in focusing 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 encompasses interim analysis, TLF shells, both blinded and unblinded reports, and organizing kick-off meetings.
7. 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, dataset generation, and quality control.
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 their relevance to client requirements.
10. Responsible for creating and updating Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.

EDUCATION AND EXPERIENCE REQUIRED

1. 10+ years of experience as a Biostatistician, working in a CRO/Pharma/Biotech company.
2. 3+ years of experience leading teams of biostatisticians and statistical programmers in a CRO/Pharma/Biotech setting.
3. MSc or PhD in Biostatistics or Statistics.
4. Strong written and verbal communication skills, including proficiency in English and the ability to explain complex statistical concepts to non-statisticians.
5. Proficient in statistical programming languages such as SAS, R, or Python.
6. Proficient in BASE, STAT, MACRO, and GRAPH, with understanding of database structures and TLF proficiency.
7. Capable of directing and promoting teamwork in a multidisciplinary environment.
8. Strong knowledge of regulatory guidelines and statistical methodologies related to clinical development.
9. Excellent communication skills, both written and verbal.
10. Ability to coach and mentor new team members for efficient onboarding.
11. Experience in cross-functional collaboration and stakeholder management.