Hybrid Biostatistics Associate Director — Clinical Trials

CSL Vifor; Amsterdam; Hybride; EUR 186 000 - 220 000; Plein temps

Résumé du poste

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program.

(There are 2 positions available supporting multiple Therapeutic Areas) This role requires PhD or MS with extensive drug development experience and a strong track record in regulatory submissions, CRO

Qualifications

• PhD or MS with extensive drug development experience.
• Experience providing statistical leadership at compound/indication level.
• Strong track record in facilitating and optimizing clinical development strategy.
• Experience in regulatory submissions.

Responsabilités

• Lead full scope of Biostatistics conduct for the responsible program and define statistical strategy.
• Influence and contribute to clinical development plans with cross-functional teams.
• Lead statistical planning and execution for trials and regulatory submissions.
• Provide for project-wide analyses and timely delivery of interim and final results.

Connaissances

Statistical leadership

Cross-functional collaboration

Communication in English

Regulatory interactions

Formation

PhD in a relevant field

MS in a relevant field

Outils

SAS

R

Description du poste

The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program.

(There are 2 positions available supporting multiple Therapeutic Areas) This role requires PhD or MS with extensive drug development experience and a strong track record in regulatory submissions, CRO