Principal Biostatistician

• Contribute to advancing life-changing therapies through statistical excellence
• Work as part of the Clinical Research team in the Functional Service Provider (FSP) division
• Work closely with clients while utilizing the resources of an established clinical research leader
• Implement diverse statistical tasks throughout the full clinical trial process
• Contribute to study design and protocol writing
• Perform final analysis and reporting
• Support advanced clinical development programs and impact health outcomes

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biostatistical experience in clinical research, with emphasis on Phase I-III trials
• Preferred Fields of Study: Statistics, Biostatistics, or related quantitative field
• Expert-level proficiency in SAS programming and statistical methodology
• Strong knowledge of ICH-GCP guidelines and clinical trial regulations
• Demonstrated experience in statistical analysis plan development and review
• Ability to manage multiple clinical trials simultaneously
• Advanced knowledge of CDISC standards and their implementation
• Experience with statistical software packages such as R, EAST, or WinBUGS
• Strong analytical and problem-solving skills
• Excellence in written and verbal communication
• Ability to interact effectively with regulatory authorities (FDA, EMA)
• Experience in CRO environment and vendor management preferred
• Knowledge of auto-immune and/or oncology therapeutic areas beneficial
• Demonstrated ability to work collaboratively in teams
• Ability to meet deadlines and manage competing priorities
• Strong attention to detail and quality focus

• Fully remote work arrangement
• Standard Monday–Friday work schedule