Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the lead biostatistician for Pulmovant's Phase 3 PHrontier program, which includes the development of protocols, statistical analysis plans (SAPs), and calculations for sample size and power.

• Collaborate with Clinical Development and Regulatory teams on decisions related to trial design, including the selection of endpoints and strategies for interim analysis.

• Supervise the biostatistics deliverables from CROs/vendors, ensuring adherence to quality standards and timelines.

• Provide statistical insights for regulatory submissions, encompassing NDA/BLA filings and responses to inquiries from health authorities.

• Work in conjunction with Data Management to design case report forms (CRFs), establish the database structure, and uphold data quality standards.

• Present statistical findings and methodologies to both internal leadership and external stakeholders, such as Data Safety Monitoring Boards (DSMBs) and advisory boards.

• Guide and mentor junior biostatistics personnel or contractors as the function expands.

• Contribute to departmental initiatives, standards, process enhancements, talent development, resource planning, and readiness for inspections.

⛳️ Requirements

• PhD or MS in Biostatistics, Statistics, or a related discipline.

• Over 8 years of experience in biostatistics within clinical drug development, specifically with direct involvement in Phase 3 trials.

• Profound expertise in SAS and/or R for the analysis of clinical trials.

• Strong understanding of ICH/FDA statistical guidance, Good Clinical Practice (GCP), ICH standards, and CDISC principles.

• Experience in managing relationships with CRO biostatistics teams.

• Outstanding cross-functional communication abilities, capable of conveying statistical insights to non-statistical stakeholders.

• Comfortable working in a lean, rapidly growing clinical-stage environment.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance options.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuing education.

• Flexible working hours and a supportive work culture.