Senior Biostatistician - Remote

Overview

We are seeking an experienced and highly motivated Senior Statistician to join our Biometrics team, providing statistical support for clinical trials across multiple therapeutic areas.

In Short

• Provide statistical support for Phase I–IV clinical trials.
• Participate in protocol development, study design, and sample size calculations.
• Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications.
• Perform statistical analyses and interpret study results.
• Collaborate with Clinical Data Management, Statistical Programming, Medical Writing, and Clinical Operations teams.
• Review outputs, tables, listings, and figures for accuracy and consistency.
• Support regulatory submissions including ISS/ISE and responses to health authority queries.
• Ensure compliance with CDISC, ICH-GCP, and regulatory guidelines.
• Contribute to process improvements and mentoring of junior statisticians.
• Participate in client meetings and provide statistical expertise to sponsors.

Requirements

• Master’s or PhD in Statistics, Biostatistics, Mathematics, or related field.
• Minimum 5–8 years of experience in biostatistics within CRO, pharmaceutical, or biotech industry.
• Strong knowledge of clinical trial methodology and statistical principles.
• Experience with SAS and/or R programming.
• Familiarity with CDISC standards (SDTM/ADaM).
• Experience supporting regulatory submissions is preferred.
• Excellent communication, problem-solving, and organizational skills.
• Ability to manage multiple projects and work independently.

Benefits

• Opportunity to work directly for a single sponsor while being part of a global CRO.
• Career development opportunities.
• Dynamic work environment.
• Supportive team culture.