Senior Biostatistician in London

We are seeking an experienced Senior Biostatistician to provide statistical leadership across clinical development programs. This role offers the opportunity to work closely with senior clinical, scientific, and operational stakeholders, supporting the design, analysis, interpretation, and reporting of clinical studies while ensuring compliance with regulatory requirements and industry standards.

Key responsibilities include:

• Delivering robust statistical strategies that support clinical development decision‐making, regulatory submissions, and overall program success.
• Leading the statistical design and methodology of clinical trials, including endpoint selection and sample size determination.
• Providing statistical input into study protocols, case report forms (CRFs), and data collection methodologies.
• Developing, reviewing, and implementing Statistical Analysis Plans (SAPs).
• Preparing and reviewing statistical sections of study synopses, protocols, clinical study reports, and regulatory documentation.
• Collaborating closely with clinical operations, data management, and cross‐functional study teams to maintain data quality and study integrity.
• Conducting and overseeing statistical analyses using appropriate methods, including regression modelling, survival analysis, Bayesian techniques, and other advanced methodologies where applicable.
• Interpreting study data and communicating key findings to both technical and non‐technical stakeholders.
• Ensuring the accuracy, quality, and regulatory compliance of all statistical deliverables.
• Supporting regulatory submissions, integrated analyses, and responses to health authority queries.
• Participating in safety review meetings, data monitoring activities, and governance committees as required.
• Ensuring compliance with ICH guidelines, GCP requirements, and internal quality standards.
• Contributing to process improvement initiatives and the modernization of clinical research practices.
• Supporting the development and revision of Standard Operating Procedures (SOPs).
• Sharing statistical expertise across the broader Clinical Affairs organization.
• Staying current with developments in biostatistics, clinical research methodology, and regulatory requirements.
• Delivering training and knowledge‐sharing sessions where appropriate.
• Supporting additional Clinical Affairs projects and initiatives as required.

Candidate Profile:

• Education: MSc or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
• Experience: 5+ years' experience in biostatistics within the pharmaceutical, biotechnology, or CRO sectors. Demonstrated experience supporting clinical trials across multiple development phases. Experience contributing to regulatory submissions and interactions with health authorities is highly desirable. Strong understanding of ICH‐GCP and clinical research regulations.
• Technical Skills: Strong statistical programming skills using SAS and/or R. Experience with data visualization and statistical reporting. Thorough understanding of clinical trial design, analysis, and interpretation. Familiarity with CDISC standards, including SDTM and ADaM. Knowledge of advanced statistical methods such as adaptive trial designs, real‐world evidence analyses, or machine learning applications is advantageous.
• Personal Attributes: Strong analytical and problem‐solving capabilities. Excellent communication skills with the ability to explain complex statistical concepts clearly. Ability to lead projects and work effectively within multidisciplinary teams. High attention to detail and commitment to quality and scientific excellence.

What's on Offer:

• Competitive salary and comprehensive benefits package.
• Opportunity to play a key role in the development of innovative therapies that can significantly improve patients' lives.
• Exposure to senior stakeholders and strategic decision‐making.
• Collaboration with highly experienced scientific and clinical professionals.
• A dynamic and growing environment that combines scientific innovation with commercial success.