Director, Biostatistics

Pulmovant

. Serve as lead biostatistician for Pulmovant's Phase 3 PHrontier program, including protocol development, statistical analysis plans (SAPs), and sample size/power calculations .

Posted 9/23/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics with a focus on clinical drug development, particularly in Phase 3 trials. Proficient in statistical analysis, regulatory submissions, and cross-functional collaboration to ensure data integrity and compliance.

Highest-signal resume keywords

PhD Or MS In Biostatistics8+ Years Of Biostatistics ExperienceSAS And/or R ProficiencyICH/FDA Statistical Guidance KnowledgeCRO Biostatistics Relationship Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlansSample Size CalculationsPower CalculationsProtocol DevelopmentInterim Analysis StrategyData Quality StandardsCRF DesignNDA/BLA SubmissionsStatistical Methodology PresentationProcess Improvements

Soft Skills

Cross-Functional CommunicationMentoringCollaboration

Industry Keywords

Clinical Drug DevelopmentPhase 3 TrialsGCPICH StandardsCDISC Principles

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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