Senior Director, Biostatistics Lead — Global Clinical Strategy

Alfasigma; Milano; Hybrid; EUR 150,000 - 190,000; Full time

Job summary

Alfasigma in Milan, Italy, seeks a Senior Director, Biostatistics Lead to drive statistical strategy across therapeutic areas and clinical development. You will provide SME input on plans, study reports, and regulatory submissions, and you will lead a talented biostatistics team while partnering with CROs and cross-functional colleagues to ensure high-quality, timely deliverables.

The role requires deep expertise in GCP/ICH, CDISC SDTM/ADaM, and advanced statistical methods, with a track record

Qualifications

• PhD in statistics/biostatistics with 15 years of pharma experience or Master with 18+ years.
• 10 years direct management of biometrics teams preferred.
• Proficiency with SAS and statistical tools (EaST, R, S-Plus) and Unix/Cloud computing.
• CDISC SDTM and ADaM knowledge.
• Strong verbal and written English communications.

Responsibilities

• Lead and oversee biostatistics activities across clinical programs.
• Provide SME input to development plans, protocols, and regulatory submissions.
• Oversee outsourced biostatistics with vendor governance.
• Drive cross-functional harmonization and SOP development.
• Ensure regulatory compliance and inspection readiness.

Skills

SAS

R

S-Plus

EaST

CDISC

GCP/ICH knowledge

English communication

Education

PhD in statistics/biostatistics

Master’s in statistics/biostatistics

Management experience

CDISC SDTM/ADaM knowledge

English communication skills

Tools

Unix

Cloud-based computing

PC office software

Job description

Alfasigma in Milan, Italy, seeks a Senior Director, Biostatistics Lead to drive statistical strategy across therapeutic areas and clinical development. You will provide SME input on plans, study reports, and regulatory submissions, and you will lead a talented biostatistics team while partnering with CROs and cross-functional colleagues to ensure high-quality, timely deliverables.

The role requires deep expertise in GCP/ICH, CDISC SDTM/ADaM, and advanced statistical methods, with a track record