Principal Biostatistician – Safety

This is a fully remote position, open to applicants in United Kingdom, +7 more countries.

📋 Description

• Play a vital role in promoting transformative therapies through statistical excellence.

• Collaborate closely with clients within the Functional Service Provider (FSP) division.

• Execute a variety of statistical tasks across the entire clinical trial lifecycle.

• Assist in the development of study designs and the writing of protocols.

• Conduct final analyses and prepare reports.

• Support advanced clinical development initiatives.

• Contribute to clinical research programs and generate scientific evidence aimed at understanding treatments and enhancing patient outcomes.

⛳️ Requirements

• A Master’s degree plus 6 years of experience, or a Bachelor’s degree plus 8 years of biostatistical experience in clinical research, particularly in Phase I-III trials.

• Preferred fields of study include Statistics, Biostatistics, or a related quantitative discipline.

• Proficiency at an expert level in SAS programming and statistical methodologies.

• Comprehensive understanding of ICH-GCP guidelines and clinical trial regulations.

• Proven experience in developing and reviewing statistical analysis plans.

• Demonstrated experience in benefit-risk analysis, safety reporting (DSUR, PSUR), post-marketing analysis, MA, RWE, and claims databases.

• Capability to manage multiple clinical trials concurrently.

• Advanced understanding of CDISC standards and their application.

• Familiarity with statistical software packages such as R, EAST, or WinBUGS.

• Strong analytical and problem-solving abilities.

• Excellent written and verbal communication skills.

• Ability to interact effectively with regulatory authorities (FDA, EMA).

• Experience in a CRO environment and vendor management is preferred.

• Knowledge of auto-immune and/or oncology therapeutic areas is advantageous.

• Demonstrated ability to work collaboratively within teams.

• Capability to meet deadlines while managing competing priorities.

• Strong attention to detail and a focus on quality.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.