Principal Statistical Programmer

🕒 Agosto 31

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $112.000 - $175.000 / ano

⏰ Tempo Integral

🔴 Especialista

🖥 Engenheiro de Software

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Esta empresa já patrocinou vistos H1B no passado.

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Everest Clinical Research

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2004

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

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 levels of complexity, challenges, and difficulty • Resolve complex statistical programming issues and problems • Coordinate study teams, oversee timelines, assign and follow up on programming tasks, interact with clients, and ensure quality programming deliverables • Assist management with planning and allocating resources based on timelines, skills, expertise, and availability • Develop and maintain clinical trial data and statistical programming standards • Perform primary statistical programming and validation programming for phase I–IV clinical trials, integrated clinical summaries, regulatory agency requests, publication support, data explorations, and data monitoring committee meetings • Create and QC-review SDTM mapping specifications and ADaM data specifications • Create and QC-review SDTM and ADaM define.xml files • Perform third-level QC review of programming deliverables before client release • Review and assess regulatory submission programming documents, datasets, tables/listings/graphs, and computer programs • Lead programming efforts for drug development programs or assigned client clusters • Train, mentor, and provide technical guidance to less experienced Statistical Programmers or Biostatisticians • Monitor compliance with established data and programming standards and governing documents • Represent the company in sponsor interactions regarding statistical programming projects and related business • Develop statistical programming policies, SOPs, guidelines, and working practices • Participate in project bidding and bid defense meetings • Plan and perform archival of statistical programming datasets, outputs, documents, and final programs • Transfer archived files to clinical trial sponsors

🎯 Requisitos

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields • 10 years’ related experience with an M.Sc. or M.A., or 9 years’ related experience with a Ph.D. • In-depth knowledge of clinical trial data processing and manipulation • Hands-on statistical programming and analysis experience • Knowledge of requirements for assembling and presenting trial results to regulatory agencies • Knowledge of industry standards for clinical trial data structure, storage, analysis, and presentation • Knowledge of clinical trial regulatory and ICH requirements • Ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies • In-depth understanding of standardization in data, programming, and statistical reporting of trial results • Sound technical judgment and experience in process design and implementation • Strong leadership and drive to achieve goals

🏖️ Benefícios

• Medical coverage • Dental coverage • Vision coverage • Life & AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement plan • Generous paid time off • Sick leave • Opportunity to earn a performance based bonus