Associate Director, Biostatistics (2)

The Associate Director, Biostatistics, leads the full scope of statistical contribution to a clinical development program, providing statistical strategies for clinical trials and regulatory submissions and is accountable for statistical deliverables within the program. Positions are available supporting multiple therapeutic areas.

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans, collaborating with cross-functional teams for governance reviews.
• Lead statistical strategy for planning and study execution as a member of Study Executive Team and Clinical Development Team, and provide 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.
• Project-wide planning of analyses; ensure quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
• Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents.
• Manage outsourcing operations or work with internal statistical programmers within the responsible program.
• Ensure timeliness and quality of deliverables by CRO/FSP.
• Support or lead improvement initiatives within the department, organization, and/or pharma industry.
• Prepare abstracts, posters, oral presentations, and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.