Director Biostatistician

Overview

• Lead statistical activities for late-phase clinical development programs, ensuring innovative trial designs and regulatory compliance.
• Collaborate with multidisciplinary teams to provide statistical expertise and guidance for clinical trials and regulatory submissions.
• Mentor and manage biostatisticians, fostering teamwork and ensuring adherence to departmental standards.
• Prepare statistical analysis plans, interpret trial results, and contribute to scientific manuscripts and regulatory documents.
• Represent the organization in regulatory meetings and interactions with stakeholders, ensuring high-quality statistical deliverables.
• Contribute to the development and implementation of SOPs and industry best practices.
• Provide statistical consultation to internal teams on various research and development projects.

Key Responsibilities & Duties

• Design innovative clinical trials and write statistical sections of protocols.
• Develop and approve stratification/randomization schemas and statistical analysis plans.
• Collaborate with data management and programming teams on trial data analysis and reporting.
• Interpret and communicate statistical results for regulatory submissions and scientific publications.
• Provide statistical guidance for ongoing trials and eCRF design.
• Lead biostatistics support for worldwide regulatory submissions and stakeholder meetings.
• Manage internal and vendor statistical resources, ensuring timely delivery of quality outputs.
• Contribute to the development of SOPs and promote innovation within the team.

Job Requirements

• Ph.D. in Statistics or Biostatistics with 8-10 years of pharmaceutical statistics experience.
• Proficiency in SAS and R programming languages, and familiarity with CDISC standards.
• Experience in clinical development through Phase 3 and NDA submissions.
• Understanding of ICH GCP and industry best practices.
• Experience with Bayesian and adaptive clinical trial designs.
• Strong communication and leadership skills to manage teams and projects effectively.
• Interest in biological processes and drug development for rare genetic diseases.