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Associate Director, Epidemiological Statistical Programming

Stelle nicht auf LinkedIn

🕒 vor 2 Monaten

⏰ Vollzeit

🟠 Senior

👔 Direktor

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Veröffentlicht auf der Karriereseite von Clinical Outcomes Solutions, nicht über eine Jobbörse

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Clinical Outcomes Solutions

51 - 200 Mitarbeiter

💼 Beratung

🏥 Gesundheitswesen

🧬 Biotechnologie

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions ist eine globale klinische Beratungsgesellschaft, die umfassende Unterstützung und Dienstleistungen in allen Aspekten der Bewertung klinischer Ergebnisse (Clinical Outcome Assessment, COA) bietet. Das Unternehmen trägt zur Verbesserung der Patientenversorgung bei, indem es die Stimme des Patienten durch innovative wissenschaftliche Methoden erfasst. Es leitet Organisationen durch die Komplexität der Forschung zu klinischen Ergebnissen, indem es Strategien und Lösungen entwickelt, um präzise Daten zu erfassen. Pharma- und Biotechnologieunternehmen vertrauen der Firma, um die Einhaltung der Vorschriften und optimierte Patientenergebnisse zu gewährleisten.

Beschreibung

• Provide technical and functional leadership to statistical programmers supporting epidemiological and real-world evidence studies • Mentor team members and promote consistent, high-quality programming practices • Lead and contribute hands-on to statistical programming activities across multiple therapeutic areas • Translate study objectives, protocols, and statistical analysis plans into robust and reproducible analytical solutions • Develop, validate, and maintain SAS and/or R programs for analysis datasets, statistical outputs, tables, figures, and other data products • Collaborate with epidemiologists, statisticians, data scientists, and cross-functional stakeholders • Provide expert consultation on complex programming, data, and analytical challenges • Oversee and review programming deliverables for accuracy, reproducibility, quality, timelines, and standards compliance • Support programming using claims, EHR, registry, and other healthcare databases • Develop analysis-ready datasets, programming specifications, derivation logic, quality-control procedures, and documentation • Establish and promote programming standards, reusable tools, macros, code libraries, documentation, and quality-control processes • Drive automation, standardization, continuous improvement, and scalable programming approaches • Plan and prioritize programming activities while identifying resource needs, risks, dependencies, and delivery challenges • Support regulatory and health authority requests, publications, abstracts, presentations, and other evidence-generation activities • Ensure compliance with regulatory requirements, company policies, SOPs, data privacy requirements, and industry best practices • Develop and maintain SOPs, work instructions, programming conventions, and related documentation • Foster collaboration and develop programming talent through coaching, knowledge sharing, technical review, and mentorship

🎯 Anforderungen

• Bachelor’s degree or higher in Statistics, Biostatistics, Epidemiology, Computer Science, Data Science, Mathematics, or a related quantitative discipline • 8+ years of relevant statistical programming experience in the pharmaceutical, biotechnology, CRO, healthcare, or life sciences industry • Demonstrated experience supporting epidemiological, observational, real-world evidence (RWE), HEOR, and/or related research • Experience with Optum and Truveta • Advanced programming expertise in SAS and/or R • Ability to develop, validate, and maintain complex analytical programs and reproducible programming workflows • Strong experience with large and complex healthcare data sources, including administrative claims, electronic health records (EHR), patient registries, or other real-world data sources • Understanding of epidemiological study designs and statistical analysis methods • Proven technical leadership and guidance of statistical programmers • Experience leading or coordinating programming activities across multiple projects • Experience overseeing and reviewing programming deliverables • Experience with line managing a team • Commitment to programming quality, reproducibility, documentation, programming standards, and best practices • Ability to work independently and manage multiple priorities • Excellent written and verbal communication skills • Strong collaboration and leadership skills • Preferred: experience across multiple epidemiological and real-world data sources and/or therapeutic areas • Preferred: experience supporting regulatory-grade RWE, regulatory submissions, health authority requests, or other evidence-generation activities • Preferred: experience with Python, SQL, Git, Unix/Linux, R Markdown/Quarto, Shiny, or similar tools • Preferred: experience developing reusable programming tools, packages, macros, automated workflows, or similar solutions • Preferred: experience contributing to programming standards, SOPs, work instructions, technical guidance, or organizational best practices • Preferred: experience with cloud-based analytics platforms and/or modern data environments

🏖️ Vorteile

• Consistent training, development, and support • Significant professional growth opportunities

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