Manager/Senior Manager, Statistical Programming

🕒 il y a 5 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 22%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Pulmovant

Site WebLinkedInTous les Emplois

11 - 50 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Pulmovant est une entreprise dédiée à transformer la vie des patients atteints de maladies pulmonaires en développant des thérapies innovantes. Leur produit phare, le mosliciguat, vise à offrir un traitement inhalé quotidien pour l'hypertension pulmonaire, se distinguant par son mécanisme novateur d'activation de la sGC. Avec un objectif unique de répondre aux besoins spécifiques des patients souffrant de pathologies pulmonaires, Pulmovant s'engage dans des essais cliniques approfondis pour faire progresser ses options de traitement pionnières.

Description

• 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

🎯 Exigences

• 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