Director, Biostatistics

Job not on LinkedIn

🔥 10 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 13%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• Serve as lead biostatistician for Pulmovant's Phase 3 PHrontier program, including protocol development, statistical analysis plans (SAPs), and sample size/power calculations • Partner with Clinical Development and Regulatory on trial design decisions, including endpoint selection and interim analysis strategy • Oversee CRO/vendor biostatistics deliverables, ensuring quality and timeline adherence • Lead statistical input for regulatory submissions, including NDA/BLA submissions and responses to health authority queries • Collaborate with Data Management on CRF design, database structure, and data quality standards • Present statistical results and methodology to internal leadership and external stakeholders, including DSMBs and advisory boards • Mentor junior biostatistics staff or contractors as the function scales • Contribute to departmental initiatives, standards, process improvements, talent development, resource planning, and inspection readiness

🎯 Requirements

• PhD or MS in Biostatistics, Statistics, or related field • 8+ years of biostatistics experience in clinical drug development, including direct Phase 3 experience • Deep expertise in SAS and/or R for clinical trial analysis • Strong understanding of ICH/FDA statistical guidance and GCP, ICH standards, and CDISC principles • Experience managing CRO biostatistics relationships • Excellent cross-functional communication skills, able to translate statistical findings for non-statistician stakeholders • Comfortable operating in a lean, scaling clinical-stage environment