Senior Director, Biostatistics Strategy & Execution

Alfasigma; Milano; In loco; EUR 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Alfasigma in Milano is seeking a Senior Director, Biostatistics Lead to drive strategic biostatistics across clinical development. You will lead a global team and collaborate with cross-functional partners to ensure high-quality, timely statistical deliverables.

You will oversee regulatory submissions, provide SME input on plans and reports, and mentor staff while maintaining vendor governance and budget oversight.

Competenze

• PhD or Master’s with extensive pharma biostatistics experience.
• Strong leadership and mentoring of biometrics teams.
• Proficiency in SAS, R, and CDISC SDTM/ADaM.
• Fluent English communications.

Mansioni

• Lead and supervise a global biostatistics team.
• Oversee regulatory submissions and eCTD NDA work.
• Ensure GMP, GCP, EMA/ICH compliance.
• Drive vendor governance and budgeting.
• Collaborate with clinical development and data management.

Conoscenze

Biostatistics leadership

GCP & ICH

Regulatory submissions

CDISC standards

Vendors management

Team development

Clinical development plans

SAS & R

Budget forecasting

Cross-functional collaboration

Formazione

PhD in statistics/biostatistics

15+ years pharma experience

Biometrics management experience

Strumenti

SAS

R

EaST

S-Plus

Unix

Cloud computing

Descrizione del lavoro

Alfasigma in Milano is seeking a Senior Director, Biostatistics Lead to drive strategic biostatistics across clinical development. You will lead a global team and collaborate with cross-functional partners to ensure high-quality, timely statistical deliverables.

You will oversee regulatory submissions, provide SME input on plans and reports, and mentor staff while maintaining vendor governance and budget oversight.