Senior Director, Biostatistics for Rare Diseases

Ipsen; Cambridge (MA); On-site; USD 270,000 - 330,000; Full time

Job summary

Ipsen Biopharmaceuticals, Inc. is seeking a Senior Director, Biostatistics for Rare Diseases. You will lead a team of biostatisticians, shaping statistical strategy for asset development, while ensuring data integrity and regulatory alignment across cross-functional teams.

The role requires extensive leadership, expertise in clinical trial design, and strong collaboration with regulatory agencies, academia, and internal stakeholders to advance Ipsen’s mission of improving patient outcomes.

Qualifications

• 10+ years in pharmaceutical industry with advanced degree; leadership experience.
• Strong track record in clinical study designs and adaptive design.
• Proficiency in descriptive and inferential statistics.
• Experience with CDISC paradigms and SDTM/ADaM.
• Excellent communication across global teams and regulators.

Responsibilities

• Provide program-level biostatistics leadership in rare disease assets.
• Lead manuscript planning, regulatory documents, and study reports.
• Direct and mentor a team of biostatisticians in a cross-functional setting.
• Collaborate with CROs, clinicians, and regulatory affairs to ensure data integrity.

Skills

Team leadership

Statistical programming

Clinical trial design

Biostatistics expertise

Regulatory submissions

Education

MS in statistics/biostatistics

PhD in statistics/biostatistics

Tools

SAS

R

EAST

nQuery

JMP

Job description

Ipsen Biopharmaceuticals, Inc. is seeking a Senior Director, Biostatistics for Rare Diseases. You will lead a team of biostatisticians, shaping statistical strategy for asset development, while ensuring data integrity and regulatory alignment across cross-functional teams.

The role requires extensive leadership, expertise in clinical trial design, and strong collaboration with regulatory agencies, academia, and internal stakeholders to advance Ipsen’s mission of improving patient outcomes.