Senior/Principal/Associate Director, Statistician (Cell-Therapy)
Core
Lead strategic and operational planning for statistical contributions to development plans, regulatory strategy, submissions, and health technology assessment for cell-therapy products.
Role type
Senior/Principal/Associate Director, Statistician (Cell-Therapy)
Builds
Regulatory submissions, health technology assessments, and commercial support for AstraZeneca products
Domain
Biopharmaceuticals / Cell Therapy / Regulatory Affairs
Deliverable
client delivery
Required skills
Statistical expertise, regulatory interaction, strategic planning, leadership, project management, risk quantification, compliance enforcement, stakeholder management, international collaboration
Preferred skills
Knowledge of emerging methodologies, therapy area development, value demonstration, contact development with opinion leaders
Technologies
None stated
Responsibilities
Lead strategic and operational planning for statistical contributions to development plans and regulatory submissions; Develop design options and provide decision support; Quantify benefit, risk, value, and uncertainty of product profiles; Set and enforce standards for statistical work; Hold CROs/partners accountable for deliverable quality; Represent company to health authorities and payer organizations; Investigate and implement statistical approaches for regulatory guidance and value demonstration; Provide leadership for improvement projects and best practice implementation; Develop contacts with international opinion leaders and collaborative groups; Ensure successful delivery of drug projects in terms of scientific leadership and resourcing
