Senior Director – Biometrics

🕒 Maio 5

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Pulmovant é uma empresa comprometida em transformar a vida de pacientes com doenças pulmonares por meio do desenvolvimento de terapias inovadoras. Seu principal produto, o mosliciguat, tem como objetivo fornecer um tratamento inalável, de uso único diário, para hipertensão pulmonar, caracterizado por seu mecanismo inovador de ativação de sGC. Com um foco singular em atender às necessidades únicas de pacientes que sofrem de condições pulmonares, a Pulmovant está engajada em extensos ensaios clínicos para avançar suas opções de tratamento pioneiras.

Descrição

• Lead, build, and oversee the Biostatistics and Statistical Programming functions, establishing standards, processes, and infrastructure to support a growing pipeline. • Serve as the senior biostatistical leader across Pulmovant’s programs, including the Phase 2 PHocus and PHactor studies of mosliciguat in PH-ILD, and future late-stage and registrational studies. • Provide strategic statistical input into protocol design, sample size justification, statistical analysis plans (SAPs), and integrated analyses (ISS/ISE) supporting regulatory submissions. • Review data quality, completeness, and key derivations • Review and provide feedback and QC on TLF shells and outputs • Ensure deliverables meet SAP specifications and quality standards • Confirm readiness of TLR package for internal/external use • Partner with Clinical Development, Regulatory Affairs, and Clinical Operations to define endpoints, estimands, and analysis strategies aligned with FDA, EMA, and other global health authority expectations. • Oversee CRO biostatistics and statistical programming deliverables, ensuring quality, timeliness, and adherence to CDISC (SDTM/ADaM), FDA, and ICH E9/E9(R1) standards. • Lead preparation of biometrics components of regulatory submissions (IND, EOP2, NDA/MAA) and represent Pulmovant in interactions with FDA and other agencies. • Drive innovative analytical approaches, including adaptive designs, Bayesian methods, and use of historical or external controls where appropriate for a rare-disease setting. • Build and lead a high-performing team of biostatisticians and statistical programmers; mentor staff and shape the talent strategy as Pulmovant scales. • Support data monitoring committees (DMCs), trial steering committees, and key opinion leader engagements. • Contribute to publications, scientific communications, and conference presentations of clinical trial results.

🎯 Requisitos

• PhD in Biostatistics, Statistics, or a closely related quantitative field (MS with extensive industry experience may be considered). • 12+ years (Senior Director) or 15+ years (Vice President) of biostatistics experience in the biopharmaceutical industry, including significant time leading biostatistics across late-stage development and regulatory submissions. • Demonstrated experience leading both Biostatistics and Statistical Programming functions, including oversight of CRO partners. • Track record of leading biostatistical strategy through successful regulatory interactions and submissions (IND, NDA/BLA, MAA); FDA submission experience required. • Prior experience in pulmonary, cardiovascular, rare disease, or interstitial lung disease therapeutic areas is strongly preferred; experience with PH or PH-ILD a plus. • Experience working in a small or mid-cap biotech and operating effectively in a lean, fast-paced environment.

🏖️ Benefícios

• Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. • We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!