- Lead statistical strategy for clinical development programs, including study design, protocol development, and statistical analysis planning.
- Plan and track biostatistics timelines, deliverables, and resources, and communicate resource needs, constraints, and risks.
- Author and review protocols, statistical analysis plans, clinical study reports, publications, and other study-level documents.
- Provide statistical input on data-management and programming deliverables, including data-collection tools and analysis datasets.
- Develop statistical programs for ad-hoc analyses, manuscripts, and presentations, and review scientific reports and publications.
- Write statistical sections of regulatory documents and collaborate with Clinical and Regulatory teams on regulatory strategy.
- Assess, select, and oversee CROs within the area of responsibility.
- Ensure compliance with company SOPs, ICH and GCP guidelines, and regulatory standards.
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