Principal Statistician – UK/Europe

🕒 vor 21 Tagen

🌐 Spanien, Vereinigtes Königreich, +3 weitere Länder – Remote

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⏰ Vollzeit

🔴 Experte

👻 Geisterscore 10%

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🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Worldwide Clinical Trials ist eine globale Auftragsforschungsorganisation (CRO) und bietet umfassende Dienstleistungen für klinische Studien. Das Unternehmen ist auf die Unterstützung von Studien in verschiedenen Therapiegebieten wie Onkologie, Kardiologie und seltenen Erkrankungen spezialisiert. Mit über 30 Jahren Erfahrung legt Worldwide Clinical Trials Wert auf persönliche Betreuung und maßgeschneiderte Lösungen über den gesamten Lebenszyklus der Arzneimittelentwicklung hinweg. Zum Serviceportfolio zählen unter anderem klinisches Monitoring, Data Management, Patient Recruitment sowie Regulatory Consulting – für Präzision und individuelle Aufmerksamkeit in jeder klinischen Studie.

Beschreibung

• Provide review of study designs, analysis plans, and reports • Contribute to clinical trial design, including protocol statistical sections, randomization methodology, and Statistical Analysis Plans • Advise on core components of study design and analysis • Support statistics reporting through specification/review of tables, figures, listing shells, derived dataset specifications, report documents, and tabulations • Prepare final reports, including tables, figures, listings, and report writing • Develop, test, and run SAS programs for statistical analysis of clinical study data • Create programs for derived datasets, SDTM/ADaM datasets, tables, figures, listings, and associated validation • Identify system and process improvements and develop and implement efficiency and quality solutions • Manage statistics support for projects or sponsor programs through timely statistical consultancy and support • Perform activities in compliance with WCT, sponsor quality systems, ICH standards, and FDA Quality System Regulation including 21 CFR Part 11 • Liaise with internal departments, sponsors, and third parties regarding statistical issues and reporting requirements • Apply current statistical methods, regulations, and software application knowledge • Review budgets and flag out-of-scope or unbudgeted items

🎯 Anforderungen

• Computer literate and numerate, with ability to adapt to various computer systems • Thorough knowledge of SAS • Knowledge of other software applications is a plus • Consultancy and facilitation skills • Customer focus, delivering on commitments, relationship building, communication, influencing, and embracing innovation and change • Appropriate degree and minimum relevant experience: BSc with 8 years, MSc with 6 years, or PhD with 4 years • Hands-on expert-level project statistician experienced in providing statistical leadership to projects • Broad statistical applications experience across all phases of clinical research • Thorough knowledge of regulatory standards and exposure to regulatory interactions • Good oral and written communication, organizational skills, and personal presentation • Ability to communicate effectively in English • Ability to prioritize and handle multiple projects simultaneously • Flexible approach, sound independent judgment, and initiative to assess information • Experience across multiple therapeutic areas

🏖️ Vorteile

• Diverse and inclusive work environment • Hands-on, accessible leaders • Cohesive and supportive teams • Opportunities to grow knowledge of SAS and CDISC standards across all phases of clinical trials • Autonomy and hands-on involvement • Support to succeed and grow • Equal employment opportunities • Exceptional employee experiences • Access to equal opportunity

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