Senior Biostatistician: Lead Complex Trials Submissions

MMS; Belfast City District; Sur place; GBP 70 000 - 110 000; Plein temps

Résumé du poste

MMS, a data-focused clinical research organization, is seeking an experienced Biostatistician in Belfast to lead complex statistical analyses and regulatory submissions. You will guide teams, review protocols, and deliver high-quality statistical outputs for sponsors in a fast-paced CGP workflow.

Ideal candidates hold a Master’s in Biostatistics (PhD preferred) with 7+ years in biostatistics, experience in ISS/ISE, and strong communication skills.

Qualifications

• Masters in Biostatistics or related field; PhD preferred.
• Minimum 7 years’ experience in Biostatistics or related field.
• Submission experience (ISS/ISE).

Responsabilités

• Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates with regulatory, PMs and sponsors.
• Develop SAPs and iSAPs text and shells with minimal supervision.
• Produce external company presentations to raise industry visibility; propose solutions aligned with direction.
• Review or develop ADAM specifications; collaborate with programmers and junior statisticians.
• Be a Subject Matter Expert in biostatistics; guide others in techniques.
• Apply drug development knowledge to complex statistical analyses.
• Draft statistical sections of Sponsor protocols and CSR; provide critical feedback.
• Prepare and review statistical methods and results sections for CSR with medical writers.
• Understand project management tasks such as timelines, scope and resources.
• Perform sample size calculations for various designs; provide consulting on study design.
• Create randomization and kit schedules; collaborate with sponsor and drug supply teams.
• Familiarity with tools used (SCM: checks in/out; external SharePoint).
• Provide DSMB support by presenting unblinded outputs.
• Stay current with industry practices and regulatory guidelines.
• Write blogs or white papers for company website.

Connaissances

Biostatistics

Statistical analysis

Project management

Communication skills

MS Office

Formation

Master’s in Biostatistics

PhD preferred

Statistics discipline or related field

Outils

MS Office

Description du poste

MMS, a data-focused clinical research organization, is seeking an experienced Biostatistician in Belfast to lead complex statistical analyses and regulatory submissions. You will guide teams, review protocols, and deliver high-quality statistical outputs for sponsors in a fast-paced CGP workflow.

Ideal candidates hold a Master’s in Biostatistics (PhD preferred) with 7+ years in biostatistics, experience in ISS/ISE, and strong communication skills.