Biogen
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Biotech
Leads biostatistical support for late-stage and early-development clinical programs, including study design, protocol development, statistical analysis plans, modeling, simulations, data analysis, and clinical study reports. Collaborates with cross-functional teams, programmers, data management, vendors, and regulatory personnel. Provides statistical expertise for submissions and legal matters, improves processes, mentors junior statisticians, and supervises assigned FSP statisticians.
Biotech
Leads end-to-end clinical biomarker strategy development and implementation for immunology and neuromuscular clinical programs, including pivotal studies. Oversees biomarker data generation, analysis, interpretation, assay development, outsourced projects, and cross-functional collaboration. Provides scientific mentorship, supports clinical trial and regulatory documentation, manages external partnerships, and engages regulators and industry stakeholders through presentations, publications, and consortia.
Biotech
Leads biostatistical strategy and deliverables for late-stage nephrology clinical development projects. Oversees clinical trial design, analyses, regulatory submissions, and evidence generation while ensuring scientific rigor and regulatory compliance. Supervises, coaches, and mentors statisticians; represents biostatistics on cross-functional teams, governance committees, regulatory interactions, and advisory boards. Drives statistical innovation, process improvement, stakeholder collaboration, and departmental capability development.
