Senior Statistical Programmer Analyst

Vaga não está no LinkedIn

🔥 6 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $65 - $115 / hora

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

👻 Score fantasma 1%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Penumbra, Inc.

Penumbra, Inc.

1001 - 5000 funcionários

Fundada em 2004

🏥 Saúde

🏭 Manufatura

⚕️ Seguro de Saúde

Healthcare • Manufacturing • Healthcare Insurance

Penumbra, Inc. é uma empresa global de saúde focada no desenvolvimento de tecnologias inovadoras para ajudar pacientes no mundo inteiro. Especializada na produção de dispositivos médicos para condições neurológicas e vasculares, a Penumbra oferece produtos como dispositivos de trombectomia, cateteres de embolização e sistemas compatíveis com RM (ressonância magnética). A empresa é dedicada a avançar o cuidado ao paciente com soluções de software de próxima geração, como o Lightning Flash 2. 0, projetado para a remoção rápida de coágulos sanguíneos e o tratamento da embolia pulmonar. A Penumbra está comprometida em melhorar os desfechos de condições como AVC, aneurisma cerebral e infarto agudo do miocárdio (IAM), sustentada por evidências clínicas e por estratégias de crescimento voltadas a investidores.

Descrição

• Prepare analysis programs supporting the preparation and statistical analysis of clinical data • Develop algorithms and write programs to create datasets following specifications • Produce and independently check data listings, summary tables, and graphs using analysis software • Import and export data • Assist data management with data edit checks and data cleaning • Maintain understanding of CDISC guidance, implementation guides, and FDA electronic-submission guidance and regulations • Keep current with industry trends in data mapping, data management, standards compliance, metadata management, and data warehousing • Prepare clinical trial datasets and programs for regulatory submission • Write analysis-dataset specifications following statistical analysis plans • Interact with project statisticians and other programmers on project teams • Manage the data warehouse used for clinical study data libraries • Collaborate with regulatory affairs, quality assurance staff, and external clinical system vendors • Mentor less experienced statistical programmers • Serve as subject matter expert on CDISC and statistical programming practices • Build SAS coding and macro libraries • Conduct work consistent with GCP, ICH, 21 CFR Part 11, SOPs, training, and regulatory requirements • Adhere to and help ensure departmental compliance with the Quality Management System and applicable regulations • Perform other work-related duties as assigned

🎯 Requisitos

• Bachelor's degree in Statistics, Computer Science, or related field with 5+ years of statistical programming experience and 3+ years of clinical statistical programming experience within the medical device or related industry, or equivalent combination of education and experience • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT • Knowledge of international regulations, requirements, and guidance associated with clinical data standards and clinical databases used for regulatory submission • Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology • Knowledge of clinical data management systems, such as Oracle InForm and/or RAVE • Expertise using SAS for data import, manipulation, analysis, export, and graph generation • Proficiency developing SAS macros to access, extract, modify, merge, and analyze clinical data • Strong oral, written, and interpersonal communication skills • High degree of accuracy and attention to detail • Proficiency with MS Word, Excel, and other standard office tools • SAS Certified Base and/or Advanced Programmer experience is preferred • Experience with macro programming, SAS/SQL, metadata repositories, and regulatory submissions is a plus • Ability to handle multiple tasks • Approximately 10% travel to conferences and/or other Penumbra affiliated facilities

🏖️ Benefícios

• Medical, dental, vision, life, AD&D, short-term disability, and long-term disability insurance • 401(k) with employer match • Paid parental leave • Eleven paid company holidays per year • Minimum of fifteen days of accrued vacation per year, increasing with tenure • Paid sick time in compliance with applicable law(s) • Collaborative teamwork environment with constant learning • Performance rewards • Opportunity to contribute to therapies for devastating diseases

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