Principal Biostatistician

MMS Belfast, Northern Ireland, United Kingdom Principal Biostatistician – Remote (UK) 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. #J-18808-Ljbffr