Director Biostatistics

Roles And Responsibilities

• Project Responsibility
• Accountable for all functional activities for at least one Compound
• Act as the functional expert within the assigned program, ensuring that activities for Evidence Generation are scientifically sound and that the evidence generated meets requirements of internal and external stakeholders
• Take responsibility as project lead for all deliverables performed by biostatisticians across the global / regional evidence generation activities
• Lead critical studies from design to analysis execution and interpretation and contribute to documents submitted to Regulatory or Pricing Authorities
• Operational Excellence and Innovation
• Sponsor, lead and participate in initiatives to improve the harmonization and efficiency of processes and develop and implement innovative solutions
• Maintain current knowledge of industry best practice in statistical methodology
• Act as Subject Matter Expert for Biostatistics, by providing guidance and support to team members and cross-functionally
• Monitor regulatory guidance and industry best practices to formulate proposals for new functional standards
• Line Management activities
• Lead a team including recruitment, coaching, mentoring, people development, talent & performance management
• Lead a cross functional project team
• Vendor Oversight
• Responsible for providing senior governance, direction, and execution of oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, regulatory and other relevant guidelines
• Responsible for CRO selection

Personal Skills And Professional Experience

• Master’s degree or PhD (preferable) in statistics, mathematics or related fields
• At least 10 years of experience as statistician (with at least 3 in Pharma) supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting
• Experience in oncology Therapeutic Area or in late phase projects is an advantage
• Extended and up-to-date knowledge of statistical methods related to clinical studies and to HEOR/HTA applications
• Knowledge of CDISC standards and statistical software such as SAS and/or R
• Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
• Demonstrated expertise in study design, conduct and execution
• Excellent English language skills
• Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
• Good negotiation and project management skills
• Demonstrated entrepreneurship and leadership and proactive problem solving
• Ability and interest to work remotely