Manager/Senior Manager, Statistical Programming

🕒 Setembro 28

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 25%

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Pulmovant

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

Healthcare • Consulting • Food & Beverage

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

• Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions • Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files • Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines • Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards • Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests • Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml • Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans • Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs • Plan and manage programming timelines and resources; oversee and quality-check deliverables from CROs and external programming vendors • Contribute to or lead departmental SOPs, work instructions, and process improvement initiatives • Mentor junior statistical programmers; provide technical guidance, code review, and professional development support • At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building

🎯 Requisitos

• Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred • 5–7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years) • Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) required • Thorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides) • Proven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submission • Strong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations • Excellent attention to detail, communication skills, and ability to manage multiple projects and priorities simultaneously • Proficiency in R for statistical programming and reporting; familiarity with Python a plus • Experience supporting NDA/BLA submissions and responding to health authority queries • Familiarity with automation tools, version control (Git), and/or cloud-based programming environments • Exposure to real-world evidence (RWE) datasets or adaptive trial designs • Experience in pulmonary, respiratory, or rare disease therapeutic areas • SAS certification (Base, Advanced, or Clinical Trials Programming) a plus

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