Director, Biostatistics - Global Clinical Strategy

Alfasigma; Antwerpen; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Opportunities for professional growth

Job summary

Alfasigma is seeking a Director of Biostatistics within Global Biometric Sciences to lead statistical strategy across development programs, influencing regulatory submissions and lifecycle decisions.

You will mentor study biostatisticians, oversee SAPs and CROs, collaborate with cross-functional teams, and stay current with regulatory guidance and innovative methods, including Real World Evidence (RWE).

Qualifications

• PhD in Statistics or Biostatistics with 10+ years in clinical trials or health research.
• Master’s in Statistics/Biostatistics with 11–12 years in biostatistics.
• Regulatory submissions experience (NDA/BLA/MAA) with health authorities.
• Capable of guiding statistical strategy across development programs.
• Experience mentoring biostatisticians and managing CROs.

Responsibilities

• Act as Program Biostatistics Lead for development programs, aligning statistical strategy with development objectives.
• Provide strategic statistical input into CDPs, endpoints and estimands across studies.
• Lead SAPs, analysis specs, and regulatory deliverables with CRO oversight.
• Mentor study biostatisticians and supervise external partners.
• Oversee statistical activities delivered by CROs and ensure regulatory compliance.
• Communicate clinical data insights to cross-functional teams and for publications.

Skills

Biostatistics leadership

Strategic influence

Cross-functional collaboration

Regulatory communication

Mentoring teammates

Education

PhD in Statistics or Biostatistics

Master’s in Statistics/Biostatistics

Tools

SAS

R

Job description

Alfasigma is seeking a Director of Biostatistics within Global Biometric Sciences to lead statistical strategy across development programs, influencing regulatory submissions and lifecycle decisions.

You will mentor study biostatisticians, oversee SAPs and CROs, collaborate with cross-functional teams, and stay current with regulatory guidance and innovative methods, including Real World Evidence (RWE).