Senior Statistical Programmer

🕒 Maio 21

🏄 California – Remoto

🏄 California – Remote

💵 $140.000 - $191.000 / ano

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

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Penumbra, Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2004

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Devices

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

• Prepares analysis programs to support the preparation and statistical analysis of clinical data. • Coordinates the statistical programming activities for multiple clinical projects. • Ensures internal consistency of output. • Assesses consistency with other projects and activities. • Follows specifications, develops algorithms and writes programs to create datasets. • Produces data listings, summary tables and graphs using analysis software. • Independently checks data listings, summary tables and graphs. • Imports and exports data. • Assists data management group in performing data edit checks to facilitate data cleaning. • Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. • Prepares clinical trial datasets and programs for regulatory submission. • Following statistical analysis plan, writes specifications for analysis datasets. • Interacts with the project statistician and other programmers participating on a project team. • Manages the data warehouse used to manage libraries of clinical study data. • Interacts with regulatory affairs, quality assurance staff, and external clinical system vendors. • Mentors less experienced statistical programmers. • Acts as the subject matter expert on CDISC and good statistical programming practices. • Builds efficient SAS coding and macro libraries. • Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements. • Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.

🎯 Requisitos

• Bachelor’s degree in statistics, computer science, or similar quantitative field, with 5+ years statistical programming experience and 3+ years of experience in clinical statistical programming within medical device or a related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)), or an equivalent combination of relevant education and applicable job experience may be considered. • Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT. • SAS Certified Base and/or Advance Programmer experience is preferred. • Experience with macro programming and SAS/SQL a plus. • Good communication skills and attention to detail are crucial. • Proven ability to handle multiple tasks. • Able to identify ways to improve business performance and campaigning for it when necessary. • 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. • Experience with metadata repository in clinical data a plus. • Experience with regulatory submissions a plus. • Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE. • Expertise at using SAS in Data Import, Data Manipulation, Data Analysis, Data Export, and Graphs. • Proficient in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data.

🏖️ Benefícios

• A collaborative teamwork environment where learning is constant, and performance is rewarded. • The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. • A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).