Principal Biostatistician

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

📋 Description

• Play a pivotal role in enhancing life-changing therapies through statistical expertise.

• Collaborate as a member of the Clinical Research team within the Functional Service Provider (FSP) division.

• Engage closely with clients while leveraging the resources of a well-established clinical research leader.

• Execute various statistical tasks throughout the complete clinical trial lifecycle.

• Assist in study design and the creation of protocols.

• Conduct final analyses and prepare comprehensive reports.

• Support advanced clinical development initiatives and influence health outcomes.

⛳️ Requirements

• Advanced degree with 6 years of experience, or a Bachelor's degree with 8 years of biostatistical experience in clinical research, particularly focused on Phase I-III trials.

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

• Expert-level proficiency in SAS programming and statistical methodologies.

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

• Proven experience in the development and review of statistical analysis plans.

• Capability to manage multiple clinical trials concurrently.

• Advanced knowledge of CDISC standards and their application.

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

• Strong analytical and problem-solving abilities.

• Exceptional written and verbal communication skills.

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

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

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

• Proven ability to work collaboratively in teams.

• Strong capacity to meet deadlines and navigate competing priorities.

• High attention to detail and a commitment to quality.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.