Senior Principal Statistician
We are partnering with an innovative biopharmaceutical organisation seeking an experienced Senior Principal Statistician to play a key role in the design, analysis, and reporting of clinical trials across the development lifecycle.
This is an opportunity to work within a highly collaborative environment, partnering with cross-functional teams to shape statistical strategy, support regulatory submissions, and influence clinical development decisions from early-phase studies through to registration.
Key Responsibilities
- Lead statistical activities for Phase I-IV clinical studies, integrated analyses, and regulatory submissions.
- Provide strategic input into study design, endpoints, sample size determination, and analysis methodology.
- Author and review Statistical Analysis Plans (SAPs).
- Oversee statistical analyses, validation activities, and interpretation of study results.
- Collaborate closely with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Project Management teams.
- Represent statistics in cross-functional study teams and governance discussions.
- Contribute to interactions with regulatory authorities and support responses to regulatory questions.
- Manage and oversee external CROs and statistical programming vendors, ensuring quality and timely delivery.
- Support the development and implementation of statistical standards, processes, and best practices.
Required Experience
- MSc, MPH, PhD, or equivalent in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
- Experience supporting clinical development programmes within a pharmaceutical or biotechnology environment.
- Strong knowledge of clinical trial design, statistical methodology, and data analysis across Phases I-IV.
- Hands-on experience with SAS and R.
- Understanding of ICH guidelines, regulatory requirements, and CDISC standards.
- Experience preparing statistical components of regulatory submissions.
- Ability to manage multiple projects in a fast-paced and collaborative environment.
- Excellent communication and stakeholder management skills.
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