Key Responsibilities:

• Serve as the statistical leader in a cross-functional development team, providing expertise in the development and implementation of clinical programs for one compound/indication.
• Contribute to the development strategy and decision-making by interpreting clinical trial data, ensuring robust statistical methodologies are applied.
• Collaborate closely with program partners and stakeholders to deliver high-quality statistical outputs for clinical trials and/or health authority (HA) submissions.
• Ensure all functional responsibilities are carried out in compliance with company guidelines and regulatory standards.
• Report to the Disease Area Team Leader, contributing to the broader biostatistics and statistical modelling efforts within the organization.

Qualifications and Skills:

• Education: Master’s or Ph.D. in Statistics, Biostatistics, or a related field.
• Experience:
• Ph.D.: Minimum 6 years of experience in a regulatory drug development environment.
• Master’s: Minimum 8 years of experience (including relevant doctoral research in biostatistics).
• Industry Expertise: Extensive experience in the pharmaceutical or biotech industry (not in a CRO) with a deep understanding of regulatory drug development.
• Technical Expertise:
• Proficiency in advanced biostatistics and its application to clinical trials.
• Expertise in Bayesian statistical methods and clinical trial design, including scenario planning.
• Strong knowledge of statistical software, including SAS and R .