FSP Principal Biostatistician, Study Powering and Design

Principal Biostatistician role supporting pharmaceutical clinical trials through study design, power calculations, and statistical analysis. Position involves collaborating with cross-functional teams on regulatory submissions and clinical development activities, based remotely in the U.S. or Canada.

Responsibilities

• Perform sample size and power calculations to optimize clinical study designs
• Author statistical analysis plans and collaborate with Data Management and Clinical Operations
• Interpret study results, review reports for accuracy, and support exploratory analyses
• Contribute to regulatory documents including clinical study reports, NDAs, DSURs, and briefing documents
• Provide guidance and supervision to programmers on analysis dataset specifications and TLF programming

Requirements

• PhD in Statistics, Biostatistics, or related field with 3+ years industry experience, or MS with 5+ years
• At least 2 years Phase 2/3 clinical trial experience
• At least 3 years experience with simulations, sample size, and power calculations
• Proficiency in R or SAS for statistical analyses
• Knowledge of CDISC standards (SDTM, ADAM, CDASH) and ADAM/TLF validation
• Understanding of FDA guidance, ICH GCP, ICH E9, estimands, and multiple imputation methods
• Strong communication skills and ability to work independently with cross-functional teams

Compensation: $96,400.00 - $309,000.00 base