Biostatistician - Clinical Trials

About the Role

Our client is seeking a skilled Biostatistician to join their growing clinical development team, supporting operations in Bristol and remotely. This role is pivotal in the design, analysis, and reporting of clinical trial data, ensuring robust statistical methodologies are applied to support drug development and regulatory submissions. You will collaborate closely with clinical scientists, data managers, and medical writers to translate complex biological and clinical questions into statistically sound research designs and analyses. This position offers a challenging and rewarding opportunity to contribute to the advancement of novel therapies within the dynamic pharmaceutical research landscape.

Key Responsibilities

• Develop statistical analysis plans (SAPs) for clinical trials in accordance with protocol objectives and regulatory requirements.
• Design clinical trial protocols, ensuring appropriate sample sizes and statistical methodologies.
• Perform statistical analyses of clinical trial data using SAS or R, and interpret the results.
• Prepare statistical sections of clinical study reports, regulatory submission documents, and publications.
• Collaborate with data management to ensure data quality and integrity for statistical analysis.
• Provide statistical expertise and consultation to cross-functional project teams.

Requirements

• Master's or PhD degree in Biostatistics, Statistics, or a related quantitative field.
• Minimum of 3 years of experience as a Biostatistician in the pharmaceutical or biotech industry .
• Proficiency in statistical software such as SAS (required) and/or R.
• Strong understanding of clinical trial design, statistical inference, and regulatory guidelines (e.g., ICH).
• Excellent analytical, problem-solving, and critical thinking skills.
• Effective communication and collaboration skills to work within multidisciplinary teams.

Benefits

• Competitive salary and performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Generous pension plan and life assurance coverage.
• Support for professional development, including attendance at statistical conferences.
• Hybrid work model to support a healthy work-life balance in the Bristol area.