Senior Biostatistics Leader, Clinical Development

CSL

Breda

Hybrid

EUR 190,000 - 225,000

Full time

7 days ago

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Benefits offered by this job

Hybrid work arrangement

Job summary

CSL is seeking an Associate Director, Biostatistics, to lead the full statistical contributions to a clinical development program. The role includes defining strategies for trials and regulatory submissions and accountability for statistical deliverables.

The position requires strong leadership in cross-functional teams, expertise in advanced methodologies, and experience with regulatory interactions. This hybrid role offers onsite work with relocation not provided and opportunities to influence

Qualifications

PhD with 8 years of drug development experience, or MS with 11 years.
Experience leading statistical aspects at compound/indication level.
Demonstrated leadership in facilitating and optimizing the clinical development strategy.
Solid experience in applications of advanced statistical methodologies.
Leading roles in regulatory submissions.
Experience with CROs preferred.
Track record of innovation preferred.

Responsibilities

Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
Define statistical strategy and ensure proper methodologies for study design and data analysis.
Influence and contribute to clinical development plans; collaborate with cross-functional teams.
Lead statistical strategy for planning and study execution; evaluate to trials and submissions.
Provide statistical thought partnership for innovative study design and Go-No Go criteria.
Oversee analyses planning and timely delivery of interim and final results.
Represent Biostatistics in interactions with regulatory authorities (FDA, EMA, PMDA).