Senior Biostatistics Leader, Research Development (Equity Eligible)

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

Benefits offered by this job

Hybrid work model

Job summary

CSL is seeking an Associate Director, Biostatistics, to lead statistical strategy for clinical development programs and ensure timely regulatory submissions. You will influence development plans, collaborate across functions, and oversee external partners to deliver high-quality results.

The role emphasizes interaction with regulatory authorities, go/no-go decision support, and communication of findings through reports and presentations.

Qualifications

• PhD or MS with required years in drug development.
• Statistical leadership at compound/indication level.
• Advanced statistical methodologies expertise.
• Experience with regulatory submissions."
• Experience with CROs is preferred."],
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Responsibilities

• Lead full scope of Biostatistics conduct for the responsible program and define statistical strategy.
• Collaborate with cross-functional teams for governance reviews.
• Interface with regulatory authorities for submissions and guidance.
• Oversee outsourcing and CRO/FSP deliverables to ensure quality and timeliness.
• Prepare abstracts, posters, and reports communicating results to stakeholders.

Skills

Statistical leadership

Regulatory knowledge

Clinical development understanding

Leadership in matrix environment

Education

PhD with 8+ years

Tools

SAS

R

Job description

CSL is seeking an Associate Director, Biostatistics, to lead statistical strategy for clinical development programs and ensure timely regulatory submissions. You will influence development plans, collaborate across functions, and oversee external partners to deliver high-quality results.

The role emphasizes interaction with regulatory authorities, go/no-go decision support, and communication of findings through reports and presentations.