Director, Biostatistics — Phase 3 Pulmonary Trials

Pulmovant; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Pulmovant seeks a Director of Biostatistics to lead our Phase 3 PHrontier program evaluating mosliciguat in PH-ILD. You will guide statistical strategy, collaborate with Clinical Development, Regulatory, and Data Management, and ensure rigorous, submission-ready trial design and analysis. Direct Phase 3 experience is essential.

The role requires advanced SAS/R skills, strong regulatory knowledge, and demonstrated leadership in cross-functional teams within a biopharma setting.

Qualifications

• PhD or MS in Biostatistics, Statistics, or related field.
• 8+ years of biostatistics experience in clinical drug development, including Phase 3.
• Prior experience contributing to regulatory submissions (NDA/BLA) preferred.
• Pulmonary/respiratory therapeutic area experience is a plus.

Responsibilities

• Serve as lead biostatistician for the Phase 3 PHrontier program, including protocol development and SAPs.
• Determine sample size and power calculations for pivotal trials.
• Collaborate on trial design decisions with Clinical Development and Regulatory.
• Oversee CRO biostatistics deliverables and timelines.
• Contribute to regulatory submissions (NDA/BLA) and health authority responses.
• Coordinate with Data Management on CRF design and data quality.
• Present results to leadership and external stakeholders; mentor junior staff.
• Support departmental initiatives and process improvements.

Skills

SAS/R analysis

ICH/CDISC/GxP

CRO management

Cross-functional communication

Education

Biostatistics degree (PhD or MS)

Tools

SAS

R

Job description

Pulmovant seeks a Director of Biostatistics to lead our Phase 3 PHrontier program evaluating mosliciguat in PH-ILD. You will guide statistical strategy, collaborate with Clinical Development, Regulatory, and Data Management, and ensure rigorous, submission-ready trial design and analysis. Direct Phase 3 experience is essential.

The role requires advanced SAS/R skills, strong regulatory knowledge, and demonstrated leadership in cross-functional teams within a biopharma setting.