Principal Biostatistician (FSP - Permanent Homebased)

IQVIA LLC; Reading; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading global provider of clinical research seeks a Principal Biostatistician to collaborate on clinical trials. The role involves writing protocols, developing analysis plans, and leading statistical teams. Ideal candidates will have a PhD or MS in Statistics with extensive industry experience, particularly in early-phase trials.

Qualifications

• 5+ years of industry experience with PhD or 7+ years with MS.
• Strong experience in early phase clinical trials.

Responsibilities

• Collaborate with project teams to establish objectives and timelines.
• Write statistical sections of clinical trial protocols.
• Develop statistical analysis plans.

Skills

Communication

Project Management

Statistical Analysis

Leadership

Education

PhD in Statistics

MS in Statistics

Tools

SAS

R

Job description

Principal Biostatistician (FSP - Permanent Homebased)

Apply at: Reading, Berkshire, United Kingdom

Job Details:

Type: Full time

Posted: 6 Days Ago

Application Deadline: May 30, 2025 (17 days remaining)

Requisition ID: R1433803

Responsibilities:

1. Collaborate with multi-disciplinary project teams to establish objectives and timelines.
2. Write statistical sections of clinical trial protocols, consulting with internal and external experts.
3. Develop statistical analysis plans.
4. Monitor project activities, including timelines, deliverables, and resources, in collaboration with Data Management, Clinical Development, and Clinical Operations.
5. Contribute to clinical study reports and regulatory documents such as DSURs and Briefing Documents.
6. Guide and supervise programmers in authoring analysis datasets and programming tables, listings, and figures.
7. Interpret study results and review reports for accuracy.
8. Support exploratory analyses and medical publications.
9. Participate in pre-IND and NDA activities.
10. Attend meetings and activities supporting Biostatistics and the Development Team as needed.

Qualifications:

• PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
• Strong experience in early phase (Phase I) clinical trials.
• Ability to work independently and manage projects effectively.
• Effective communication skills and ability to lead programmers constructively.
• Proficiency in SAS and/or R for efficacy analyses and data validation.
• Knowledge of ICH GCP, ICH E9, and industry standards.
• Experience with CDISC standards including SDTM, ADaM, and CDASH.
• At least 1 year of experience with regulatory submissions.

Desired Skills:

• Familiarity with R programming and other statistical software.

IQVIA is a leading global provider of clinical research, commercial insights, and healthcare intelligence. Learn more at https://jobs.iqvia.com