Biostatistics Director

Role: The Director serves as a statistical expert supporting the clinical development of antibody-based therapeutics, acting as a lead for specific compounds or indications. They contribute to strategies, trial design, and regulatory interactions, ensuring consistency and scientific integrity across studies.

Responsibilities

• Lead statistical activities at compound and trial levels, acting as the main contact and ensuring methodological consistency.
• Engage with regulatory authorities and contribute to development strategies, including designing trials and advanced analyses.
• Represent the organization at industry meetings, review study documents, coordinate data transfer, and oversee vendor collaborations.
• Participate in cross-functional teams, review protocols, analysis plans, and reports, and support regulatory submissions.
• Drive innovative statistical methodologies and ensure adherence to industry standards and regulations.
  
  

Qualifications & Skills

• Master’s or PhD in a statistical discipline.
• 12 years of relevant experience, including expertise in statistical analysis, modeling, adaptive trial designs, and regulatory processes.
• Experience with biologics, targeted therapies, and regulatory agencies like FDA and EMA.
• Proficiency with SDTM, ADaM, CDISC standards, and leading cross-functional projects and teams.