Biostatistics Associate Director, Clinical Development

CSL Ltd. ADR; King of Prussia (PA); Hybrid; USD 212,000 - 251,000; Full time

Job summary

CSL Behring seeks an Associate Director, Biostatistics, to lead the full statistical contribution to a clinical development program. The role defines strategy, ensures robust design and analyses for trials and regulatory submissions, and oversees deliverables across the program.

The position requires strong leadership in regulatory interactions, CRO management, and collaboration with cross-functional teams to drive successful submissions and innovative study designs.

Qualifications

• PhD or MS with extensive drug development experience and leadership in statistics.
• Strong track record in regulatory submissions for clinical programs.
• Expertise in advanced statistical methodologies and study design.
• Experience interacting with major regulators and CROs.

Responsibilities

• Lead full scope of Biostatistics conduct for the program and define statistical strategy.
• Collaborate with cross-functional teams for governance reviews and development plans.
• Lead planning and execution of analyses, including interim and final results.
• Interface with regulatory authorities, ensure accuracy in submissions.
• Oversee CRO/FSP contributions and deliverables, drive process improvements.

Skills

Statistical leadership

Regulatory submission expertise

Cross-functional collaboration

English communication

Education

PhD with 8 years of experience in drug development

MS with 11 years of experience in drug development

Tools

SAS

R

Job description

CSL Behring seeks an Associate Director, Biostatistics, to lead the full statistical contribution to a clinical development program. The role defines strategy, ensures robust design and analyses for trials and regulatory submissions, and oversees deliverables across the program.

The position requires strong leadership in regulatory interactions, CRO management, and collaboration with cross-functional teams to drive successful submissions and innovative study designs.