Principal Biostatistician
Job Summary
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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