Role Description We are seeking an Associate Director/Director Biostatistician to provide strategic and technical leadership to support and lead statistical activities for clinical trials across multiple studies. This role requires hands-on statistical expertise, strong communication skills, and the ability to lead multiple projects while collaborating closely with cross-functional teams.

Key Responsibilities

• Provide statistical leadership across one or more clinical programs, including study design, analysis strategy, and interpretation of results.
• Lead the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials.
• Serve as a key statistical representative in cross-functional team discussions and governance meetings.
• Ensure statistical approaches comply with regulatory standards and industry best practices.
• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance.
• Collaborate with cross-functional teams, including Clinical, Programming, Data Management, and Regulatory.
• Provide guidance and oversight to statistical programmers as needed.
• Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders.
• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs.

Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field.
• 10+ years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
• Strong experience supporting clinical trials across all phases.
• Excellent communication skills, with the ability to clearly explain statistical concepts to non-statistical stakeholders.
• Strong experience in Immunology clinical studies (required).
• Proven ability to lead projects and studies independently.

Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.