Principal Biostatistician

This is a fully remote position, open to applicants in Europe.

📋 Description

• Direct the statistical strategy and execution for intricate studies and programs, including submissions and multi-protocol initiatives.

• Create and assess Statistical Analysis Plans while ensuring the quality of statistical outputs.

• Oversee statistical analyses, Tables, Figures & Listings (TFLs), and study reporting.

• Work closely with cross-functional teams and serve as a vital statistical advisor.

• Assist in regulatory interactions, publications, and post hoc analyses.

• Contribute to study design, protocol development, and randomization strategies.

• Guide junior statisticians and offer technical leadership.

• Act as the representative for Biostatistics during client interactions, bid defenses, and audits.

⛳️ Requirements

• Advanced degree (MSc/PhD) in Statistics, Biostatistics, or a related discipline.

• Extensive experience as a Lead/Principal Biostatistician in a CRO, biotech, or pharmaceutical setting.

• In-depth knowledge of statistical methodologies for clinical trials and regulatory standards (FDA/EMA).

• Expertise in SAS programming (including advanced procedures).

• Strong background in CDISC standards (SDTM, ADaM, TFLs).

• Capability to articulate complex statistical concepts to a diverse range of stakeholders.

• Excellent organizational skills, meticulous attention to detail, and a collaborative approach.

• Proficient in English.

🏝️ Benefits

• Competitive salary and a comprehensive benefits package.

• Flexible, remote-friendly work environment.

• Robust career development and advancement opportunities.

• Supportive and collaborative team culture.