Staff Biostatistician

To support the expansion of the Biostatistics team, the remote Staff Biostatistician will lead statistical study design and analysis for clinical studies, ensuring accuracy in reporting and compliance for in vitro diagnostic products. Key responsibilities Provide technical expertise and statistical oversight for high complexity clinical studies, attending relevant project meetings Develop statistical sections of study protocols and ensure accurate interpretation of analysis results in reports and regulatory documents Manage operations with internal statistical programmers to ensure timely and high-quality deliverables while representing Biostatistics in regulatory interactions Required qualifications Master's degree or higher in Statistics, Biostatistics, or Math 10+ years of lead project work as a statistician on clinical trial projects Expert understanding of biostatistics processes and clinical trial design Strong programming skills in R (required) and Python (preferred) Proven project management leadership skills and experience in technical meetings with stakeholders