Statistical Programmer II

🕒 vor 1 Monat

🌲 North Carolina, Texas – Remote

🌲 North Carolina – Remote 🤠 Texas – Remote

💵 $90.000 - $100.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🖥 Softwareentwickler

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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LivaNova

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1001 - 5000 Mitarbeiter

🏭 Fertigung

🏥 Gesundheitswesen

🧬 Biotechnologie

Manufacturing • Healthcare • Biotechnology

LivaNova PLC ist ein globales Medizintechnikunternehmen, das auf nahezu fünf Jahrzehnten Erfahrung und dem unermüdlichen Engagement basiert, das Leben von Patientinnen und Patienten weltweit zu verbessern. Unsere fortschrittlichen Technologien und bahnbrechenden Therapien bieten wirkungsvolle Lösungen zum Nutzen von Patientinnen und Patienten, medizinischem Fachpersonal und Gesundheitssystemen.

Beschreibung

• Support programming activities for multiple projects on clinical study reports and publications • Accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management • Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues • Develop, validate, and maintain SAS programs in accordance with study requirements, internal standards, and SOPs • Contribute to the creation, validation, and documentation of SDTM and ADaM datasets • Responsible for producing programming outputs, validation, and related documentation to ensure accuracy, consistency, and traceability • Ensure deliverables meet expectations in terms of timelines and quality, regulatory and key user group requirements (e.g., CDISC), operational efficiency, and alignment with the study's clinical and statistical objectives • Provide input into SAP, analysis specifications, and data presentations for clinical trials • Support ongoing workflow modernization, migration activities, and standardization initiatives • Participate in process improvement activities related to programming efficiency, quality, and standardization

🎯 Anforderungen

• Bachelor’s degree or higher in statistics, mathematics, computer science, life sciences, data science, or related field • Relevant experience in clinical trial programming, clinical data analysis, statistical programming, or regulated data environments • Strong SAS programming skills, including data step, procedures, macros, and debugging • Ability to write clear, validated, reusable, and well-documented code • Understanding of programming quality control, validation, and traceability expectations • Working knowledge of CDISC standards, especially SDTM and ADaM • Ability to support dataset creation, validation, listings, tables, figures, and ad hoc analyses • Understanding of clinical trial data flow from data collection to analysis/reporting • Strong attention to detail and quality • Ability to work independently on assigned tasks with appropriate guidance • Good communication skills and ability to collaborate with Statistics, Data Management, Clinical, and external vendors • Ability to manage priorities and timelines in a changing project environment

🏖️ Vorteile

• Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus • Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules