Senior Director, Biostatistics & Clinical Strategy

Alfasigma group; Bologna, Milano; Ibrido; EUR 180.000 - 250.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Comprehensive benefits

Professional growth opportunities

Descrizione del lavoro

Alfasigma is seeking a Senior Director, Biostatistics Lead to guide biostatistical strategy across clinical programs. The role influences development plans, study design, and regulatory submissions, partnering with global teams and CROs to deliver high-quality results.

Based in Milan or another EU country, you will lead a robust biometrics function, foster innovation in study design, and ensure compliance with global regulatory standards while supporting corporate objectives.

Competenze

• PhD or Master with extensive pharma biometrics experience.
• Deep knowledge of GCP, ICH, FDA/CDISC, 21 CFR Part 11.
• Experience leading biostatistics teams and regulatory submissions.
• Strong English verbal and written communication.

Mansioni

• Provide statistical input to regulatory submissions and development plans.
• Lead and grow a biostatistics team with coaching and succession planning.
• Oversee outsourced statistics activities with CRO governance.
• Ensure compliance and inspection readiness of deliverables.
• Drive cross-functional alignment and study design innovation.

Conoscenze

Strategic leadership

GCP/ICH knowledge

Regulatory understanding

Executive communication

Problem solving

Formazione

PhD in statistics/biostatistics

Master’s in statistics/biostatistics (with 18+ years pharma experience)

Strumenti

SAS

R

S-Plus

Descrizione del lavoro

Alfasigma is seeking a Senior Director, Biostatistics Lead to guide biostatistical strategy across clinical programs. The role influences development plans, study design, and regulatory submissions, partnering with global teams and CROs to deliver high-quality results.

Based in Milan or another EU country, you will lead a robust biometrics function, foster innovation in study design, and ensure compliance with global regulatory standards while supporting corporate objectives.