Senior Biostatistician

To support the expansion of the Biostatistics team, the remote Senior Biostatistician will lead statistical study design and analysis for clinical studies, providing technical expertise and guidance for in vitro diagnostic product development and regulatory submissions. Key responsibilities Lead statistical oversight for high complexity clinical studies, attending project meetings and providing advanced guidance on study design and analysis methods Develop statistical sections of study protocols and analysis plans, ensuring accurate reporting in study reports and regulatory documents Collaborate with cross-functional teams to prepare and review statistical analyses for regulatory submissions and communicate results effectively to stakeholders Required qualifications Master's degree or higher in Statistics, Biostatistics, Bioinformatics, Data Science, or Math 6+ years of related experience with a Master's Degree or 3+ years with a PhD Expert understanding of biostatistics processes and clinical trial design Strong programming skills in R (required) and Python (preferred) Ability to thrive in a fast-paced, dynamic work environment