Statistical Programmer II

🕒 il y a 1 mois

🌲 North Carolina, Texas – Distant

🌲 North Carolina – Remote 🤠 Texas – Remote

💵 $90 000 - $100 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🖥 Ingénieur Logiciel

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LivaNova

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏭 Fabrication

🏥 Santé

🧬 Biotechnologie

Manufacturing • Healthcare • Biotechnology

LivaNova PLC est une entreprise mondiale de technologies médicales, fondée sur près de cinquante ans d'expérience et un engagement sans relâche à améliorer la vie des patients à travers le monde. Nos technologies avancées et nos traitements révolutionnaires offrent des solutions significatives au bénéfice des patients, des professionnels de la santé et des systèmes de santé. Chez LivaNova, nous comprenons l'importance de fournir à nos clients une valeur à la fois clinique et économique. Nous sommes une entreprise leader sur le marché des technologies et services médicaux, offrant un portefeuille de produits diversifié et une portée mondiale. LivaNova est cotée à la bourse NASDAQ sous le symbole "LIVN". LivaNova emploie environ 2 900 personnes dans le monde entier. Notre siège social est basé à Londres (Royaume-Uni) et nous sommes présents dans plus de 100 pays. LivaNova est un leader mondial en cardiopulmonaire et neuromodulation, dédiée à créer des produits et des thérapies significatifs qui transforment des vies chaque jour.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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