Principal Biostatistician

This is a fully remote position, open to applicants in Poland, +3 more states.

📋 Description

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

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

• Oversee statistical analyses, including Tables, Figures & Listings (TFLs), as well as study reporting.

• Work closely with cross-functional teams, serving as a vital statistical advisor.

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

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

• Mentor junior statisticians and offer technical guidance.

• Represent the Biostatistics department 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 methods applicable to clinical trials and regulatory standards (FDA/EMA).

• Proficient in SAS, including advanced functionalities.

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

• Capability to articulate complex statistical ideas to varied audiences.

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

• Proficiency in English.

🏝️ Benefits

• Robust career development and advancement opportunities.

• Competitive salary and comprehensive benefits package.

• Flexible, remote-friendly work environment.

• Supportive and collaborative team culture.