Principal Statistical Programmer

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🕒 Abril 4

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $112.000 - $175.000 / ano

⏰ Tempo Integral

🔴 Especialista

🖥 Engenheiro de Software

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Everest Clinical Research

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2004

💊 Farmacêutico

🧬 Biotecnologia

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

A Everest Clinical Research é uma organização de pesquisa por contrato (CRO) global que fornece serviços completos de ensaios clínicos e expertise em biometria para patrocinadores das indústrias farmacêutica e biotecnológica. A empresa oferece operações clínicas e gestão de projetos, gestão de qualidade baseada em risco e monitoramento centralizado, monitoramento médico, farmacovigilância, gestão de dados clínicos, bioestatística e programação estatística, estratégia regulatória e submissões, além de soluções tecnológicas como IRT/RTSM e ePRO/eCOA. A Everest se posiciona como um parceiro de alta qualidade, com alcance global e expertise terapêutica em oncologia, neurologia, doenças respiratórias, doenças raras e imunologia.

Descrição

• Lead projects with higher level of complexity/challenges/difficulties • Lead efforts to resolve complex statistical programming issues or problems • Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables • Assist statistical programming management in properly planning and allocating resources based on timelines • Participate in developing and maintaining clinical trial data and statistical programming standards • Perform hands on primary statistical programming and validation programming • Create SDTM mapping specifications and ADaM data specifications • Perform quality control (QC) review of these documents prepared by others • Perform 3rd level QC review on programming deliverables before their release to the clients • Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians

🎯 Requisitos

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields • 10 (M.Sc., M.A.)/9 (Ph.D.) years’ related experience • An in-depth knowledge of clinical trial data processing and manipulation • Hands on statistical programming and analysis • Requirements for assembling and presenting trial results to regulatory agencies • Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented • Knowledge of clinical trial regulatory and ICH requirements • Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming • Statistical analysis and submission of trial data and results to regulatory agencies • Must possess an in-depth level understanding of the concept of standardization in data

🏖️ Benefícios

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a 401(k) retirement / pension plan • generous paid time off and sick leave • the opportunity to earn a performance based bonus