Overview
We are seeking a Senior/Principal Statistician Consultant to join our in-house team on a remote basis in the UK. The successful candidate will provide statistical leadership and expertise across clinical development programs, supporting a diverse client portfolio in the pharmaceutical industry. This role involves collaborating with cross-functional teams and contributing to clinical trial design, data analysis, and regulatory submissions.
Responsibilities
- Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
- Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
- Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
- Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
- Provide statistical expertise for regulatory submissions and interactions with health authorities.
- Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
- Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
- Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Requirements
- PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
- Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
- Strong knowledge of clinical trial design, statistical inference, sample size determination, and statistical analysis methodologies.
- Experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
- Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
- Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience.
- Proficiency in statistical programming tools such as SAS and/or R.
- Strong analytical, problem-solving, communication, and stakeholder-management skills, with the ability to work independently and collaboratively.