Senior Biostatistician — Lead Clinical Statistics & SAS

MMS; Belfast City District; On-site; GBP 65,000 - 95,000; Full time

Job summary

MMS is seeking a Senior Biostatistician to join our data-focused CRO. You will lead biostatistical deliverables across trials, collaborate with sponsors and cross-functional teams, and ensure high-quality analyses aligned with CDISC standards and FDA guidance.

Qualified candidates have strong SAS skills, advanced degrees in biostatistics, and experience with SDTM/ADaM. Excellent communication and writing abilities are essential for this role in a collaborative, global environment at MMS.

Qualifications

• Excellent scientific writing skills.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
• Develop phase 1-4 SAPs and contribute to iSAPs; create SAP TLFs shells for all phases and studies.
• Review ADAM and TLFs; work with client and programmers to resolve comments.
• Provide strong programming and logic skills (SAS).
• Apply drug development knowledge during production of high-quality statistical analyses.
• Perform sample size calculations for various study designs.
• Lead projects across all phases and manage client meetings and CRMs; collaborate with regulatory and sponsor teams.
• Demonstrate knowledge of CDISC standards (SDTM/ADaM) and FDA guidance relevant to therapy areas.
• Understand the tools we work with and high-level knowledge of drug development in biostatistics.
• Provide ICH-based input for statistics and assist in CSR statistical sections with writers.

Skills

Strong communication

Problem-solving

Organizational skills

Education

Masters/PhD in Biostatistics/Statistics/Mathematics

Tools

SAS programming

SAS base

SAS macro

MS Office

Job description

MMS is seeking a Senior Biostatistician to join our data-focused CRO. You will lead biostatistical deliverables across trials, collaborate with sponsors and cross-functional teams, and ensure high-quality analyses aligned with CDISC standards and FDA guidance.

Qualified candidates have strong SAS skills, advanced degrees in biostatistics, and experience with SDTM/ADaM. Excellent communication and writing abilities are essential for this role in a collaborative, global environment at MMS.