+ Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
+ Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
+ Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
+ Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
+ Represent Biostatistics in interactions with regula...