Biostatistician - Clinical Development

About the Role

Our client, a globally recognised pharmaceutical company, is seeking a talented Biostatistician to join their Clinical Development team, offering a fully remote position based out of Belfast . In this critical role, you will be responsible for the statistical design, analysis, and reporting of clinical trials across various therapeutic areas, ensuring the integrity and validity of the data that supports drug development. You will collaborate with a multidisciplinary team of clinicians, data managers, and regulatory experts to translate complex biological and clinical data into meaningful insights that drive regulatory submissions and clinical decision-making. This is an excellent opportunity for a skilled statistician to contribute to life-changing medicines from the comfort of their home, working within a leading organisation that prioritizes data-driven research and employee well-being.

Key Responsibilities

• Design statistical analysis plans for clinical trials, including sample size calculations, statistical methods, and data interpretation guidelines.
• Perform statistical analyses of clinical trial data using SAS or R, ensuring accuracy and compliance with statistical principles.
• Develop statistical reports, tables, listings, and figures for clinical study reports (CSRs) and regulatory submissions.
• Collaborate with cross-functional teams to define data collection strategies and ensure data quality.
• Contribute to the statistical aspects of regulatory submissions (e.g., INDs, NDAs, MAAs).
• Stay abreast of the latest developments in statistical methodology and regulatory guidelines relevant to clinical development in Belfast .

Requirements

• Master's or PhD degree in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 4 years of experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proficiency in statistical software such as SAS or R.
• Strong understanding of clinical trial design, statistical principles, and regulatory requirements.
• Excellent analytical and problem-solving skills, with meticulous attention to detail.
• Ability to communicate complex statistical concepts effectively to both technical and non-technical audiences remotely.

Benefits

• Competitive salary and annual performance-based bonus.
• Comprehensive health, dental, and vision insurance.
• Generous retirement savings plan with company matching.
• Significant opportunities for professional growth and skill development.
• Fully remote work arrangement with flexibility, supporting work-life balance for our team in Belfast .