Senior Director, Biostatistics (Rare Diseases)

IPSEN; Cambridge (MA); On-site; USD 240,000 - 320,000; Full time

Job summary

Ipsen US seeks a Senior Director, Biostatistics to lead program-level statistical strategy for rare disease assets, mentor a team of biostatisticians, and partner with clinical, regulatory, and data science groups to ensure high-quality analyses and regulatory submissions.

The role emphasizes data integrity, innovative trial designs, oversight of CROs, and collaboration with external stakeholders to advance Ipsen’s mission and support strategic decisions across development programs.

Qualifications

• 10+ years in pharmaceutical industry with a PhD, or 12+ years with an MS
• At least 5 years in a leadership role overseeing biostatistics teams
• Advanced knowledge of clinical study designs and complex trials
• Hands-on SAS, R, and CDISC (SDTM/ADaM) programming experience
• Excellent communication and collaboration across global teams

Responsibilities

• Provide program-level statistical leadership for rare disease assets
• Mentor and develop a team of biostatisticians
• Lead planning and execution of biostatistics deliverables and regulatory submissions
• Oversee CROs and ensure data integrity and regulatory compliance
• Collaborate with R&D, clinical operations, regulatory, and biostatistics peers

Skills

Leadership

Biostatistics leadership

Clinical trial design

Statistical analysis

Communication

Education

MS in statistics/biostatistics

PhD in statistics/biostatistics (preferred)

Tools

SAS

R

EAST

nQuery

JMP

Job description

Ipsen US seeks a Senior Director, Biostatistics to lead program-level statistical strategy for rare disease assets, mentor a team of biostatisticians, and partner with clinical, regulatory, and data science groups to ensure high-quality analyses and regulatory submissions.

The role emphasizes data integrity, innovative trial designs, oversight of CROs, and collaboration with external stakeholders to advance Ipsen’s mission and support strategic decisions across development programs.