Principal Biostatistician Remote (UK)

MMS; Belfast; Remote; GBP 60,000 - 80,000; Full time

Job summary

A clinical research organization in Belfast is seeking a Principal Biostatistician to lead statistical analysis for clinical trials. The ideal candidate will have a Master's or PhD in Biostatistics and a minimum of 7 years' experience in the field. Key responsibilities include developing statistical analysis plans, providing expertise in drug development, and collaborating with clinical teams. This full-time remote position offers an opportunity to contribute to meaningful research in a supportive environment.

Qualifications

• Minimum of 7 years experience in Biostatistics, Statistics or similar field required.
• Expert knowledge of scientific principles and concepts.
• Good communication skills and willingness to work with others.
• Familiarity with current ISO standards preferred.
• Basic understanding of CROs and scientific data.

Responsibilities

• Create randomization and kit schedules independently.
• Develop SAPs and iSAPs text and shells without supervision.
• Lead complex project programs and submissions.
• Provide support to Data Safety Monitoring Boards.
• Produce and present statistical output as the unblinded statistician.

Skills

Business Development

Data Analysis Skills

Leadership Experience

SAS

Cloud Computing

Go

Negotiation

Education

Masters in Biostatistics or related field

PhD in related field

Tools

MS Office

AWS

Dayforce

Job description

Principal Biostatistician

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, supporting 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 maintains an industry‑leading customer satisfaction rating while fostering 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.

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

Roles and Responsibilities

• Can create randomization and kit schedules independently, collaborating with sponsor randomization and drug supply management teams.
• Can develop SAPs and iSAPs text and shells with no supervision.
• Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments.
• High technical level Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.
• Has the ability to apply drug development knowledge during production of complex statistical analyses.
• Can perform sample size calculations for a variety of scenarios and study designs; can provide statistical consulting support to sponsors re study design and sample size calculations.
• Leads complex project programs and submissions, manages client meetings, CRMs, collaborates well with regulatory PMs and sponsors.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Understands the various tools that we work with and is able to use them correctly (for SCM : checks in / out; use of external SharePoint).
• Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Has high level knowledge of drug development as it pertains to biostatistics.
• Produces and presents external company presentations providing industry visibility for the organization; continually suggests solutions to solve issues in tune with organizational direction.
• Writes blogs and/or white papers for posting on the company website.
• Reviews or creates the statistical section(s) of a sponsor’s protocol and ensures that the appropriate statistical methods are proposed for the study design and objectives. Provides valuable feedback to the sponsor on the statistical aspects of the study.
• Has high proficiency with MS Office applications.
• Demonstrates an understanding of project management‑related tasks such as timelines, scope and resource requirement estimation/management.
• Prepares and reviews 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 required.
• 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 & the drug development process.

Key Skills

• Business Development
• Classroom Experience
• Dayforce
• Go
• Cloud Computing
• AWS
• Teaching
• Administrative Experience
• Leadership Experience
• Negotiation
• SAS
• Data Analysis Skills

Employment Type: Full‑Time

Experience: years

Vacancy: 1