Principal Biostatistician - Remote (UK) in Belfast

This is a full‑time, home‑based role for candidates based within the UK.

Roles & Responsibilities

• Can create randomization and kit schedules independently, collaborating with sponsor, randomization, and drug supply management teams.
• Develop SAPs and iSAPs text and shells with no supervision.
• Review or develop ADAM specifications; work with programmers and junior statisticians to resolve comments.
• High technical level and Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.
• Apply drug development knowledge during production of complex statistical analyses.
• Perform sample size calculations for a variety of scenarios and study designs, and provide statistical consulting support to sponsors regarding study design and sample size calculations.
• Lead complex projects, programs and submissions; manage client meetings and CRMs, and collaborate well with regulatory, PMs and sponsor.
• Stay current with latest industry practices and updated regulatory guidelines.
• Use tools such as SCM, SharePoint appropriately.
• Support Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Produce and present external company presentations providing industry visibility for the organization; continually suggest solutions to solve issues in tune with organizational direction.
• Write blogs and/or white papers for posting on the company website.
• Review or create the statistical section(s) of a Sponsor’s protocol and ensure appropriate statistical methods are proposed for the study design and objectives.
• Provide valuable feedback to the Sponsor on the statistical aspects of the study.
• High proficiency with MS Office applications.
• Demonstrate understanding of project management‑related tasks such as timelines, scope and resource requirement estimation/management.
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in‑house medical writers.

Requirements

• Masters in Biostatistics, Statistics discipline or related field, or related experience; PhD preferred.
• Minimum of 7 years’ experience in Biostatistics, Statistics or similar field.
• Submission experience (ISS/ISE).
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem‑solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Basic understanding of CROs and scientific & clinical data/terminology, and the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.