Senior Biostatistician - Remote (UK) in Belfast

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award‑winning, data‑focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry‑leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Responsibilities:

• Create randomization and kit schedules independently, collaborating with sponsor, randomization and drug supply management teams.
• Develop phase 1‑4 SAPs and make significant contributions to iSAPs; create SAP TLF shells for all phases and studies.
• Review ADaM and TLFs; work with client and programmers to resolve comments.
• Strong programming and logic skills (working knowledge of SAS).
• Apply drug development knowledge during production of high‑quality statistical analyses.
• Perform sample size calculations for a variety of scenarios and study designs.
• Lead projects (all phases and even a program of studies) and smaller submissions, manage client meetings, CRMs, and collaborate well with regulatory, PMs and sponsor.
• Strong knowledge of CDISC (especially SDTM and ADaM), understand guidance from FDA across different therapeutic areas.
• Understand the various tools that we work with.
• High‑level knowledge of drug development as it pertains to biostatistics.
• Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Review the statistical section of a Sponsor’s protocol and ensure the appropriate statistical methods are proposed for the study design and objectives; provide valuable feedback and create the statistical section with minimal support.
• High proficiency with MS Office applications.
• Demonstrate an understanding of project‑management related tasks such as timelines, scope and resource requirements.
• Provide ICH guideline‑based input as applicable to statistics.
• Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in‑house medical writers.

Requirements:

• College graduate in Biostatistics, Statistics, Mathematics or related field; master’s or PhD preferred, or many years of related experience required.
• Minimum of 5 years’ experience in Biostatistics or a similar field.
• Expert knowledge of scientific principles and concepts.
• Strong SAS programming (SAS base, SAS macro) experience.
• Thorough knowledge and understanding of clinical data.
• Strong experience with data and production of TLGs.
• Excellent scientific writing skills.
• Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
• 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 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.