Associate Director, Biostatistics
About this role
About the Role Associate Director of Biostatistics to join our rapidly growing organization. This role supports the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions, working cross-functionally to ensure regulatory compliance and adherence to SOPs, while contributing to biostatistics standards and innovation.
What You'll Do
- Serve as study biostatistician on development programs and multiple studies.
- Author statistical analysis plan, TFL shells and other study-related statistical documents.
- Review AdaM Specification, oversee the generation of AdaMs and TFLs and ensure timely high-quality deliverables.
- Plan and implement statistical analyses, provide statistical input to the clinical study report and perform statistical functions for submission-related activities on the assigned programs.
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