Principal Biostatistician

Responsibilities:

• Generate and verify randomization schedules, sample size calculations, and advanced statistical calculations including adaptive designs.
• Author statistical analysis plans, develop table/figure/listing shells, and review work from other biostatisticians.
• Provide statistical support to Data Monitoring Committees and regulatory submissions.

Qualifications:

• Master's degree in Statistics, Biostatistics, or related field with 10+ years of experience; or PhD with 7+ years of experience.
• Deep expertise in SAS programming and clinical trial statistics, with knowledge of ICH guidelines, CDISC, 21 CFR Part 11, and FDA regulations.
• Preferred experience in oncology, rare diseases, late phase trials, and client consulting.

Skills & Competencies:

• Mastery of statistical principles and SAS programming, with outstanding problem-solving and presentation skills.
• Excellent consultative, organizational, and communication abilities to coordinate workloads and interface with global teams.
• Sound judgment, decision-making, and service orientation to build effective working relationships.