Working remotely as a full-time Principal Biostatistician, the successful candidate will provide high-level consulting for statistical analysis and programming in clinical trials, develop statistical analysis plans, and ensure compliance with industry standards. Key responsibilities Provide consulting on statistical activities related to clinical trials and fulfill the responsibilities of a study statistician Develop, review, and finalize statistical analysis plans while validating programming deliverables and collaborating with team members Analyze data to contribute to trial progression decisions and ensure that all client work meets or exceeds expectations Required qualifications Master's degree in Statistics or Biostatistics preferred 10+ years of experience in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role Strong experience with clinical study design development, analysis, and sample size determination Knowledge of ICH guidelines, GCP, and regulatory requirements including FDA and EMEA Experience in developing statistical analysis reports and conducting statistical analyses for trial-level deliverables
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