Senior Statistical Programmer

🕒 il y a 21 jours

🏄 California – Distant

🏄 California – Remote

💵 $140 000 - $191 000 / an

⏰ Temps Plein

🟠 Senior

🖥 Ingénieur Logiciel

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Penumbra, Inc.

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2004

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. est une entreprise mondiale de soins de santé, spécialisée dans le développement de technologies innovantes pour aider les patients à travers le monde. Spécialisée dans la production de dispositifs médicaux pour les conditions neurovasculaires, Penumbra propose des produits tels que des dispositifs de thrombectomie, des cathéters d'embolisation et des systèmes compatibles IRM. L'entreprise s'engage à faire progresser les soins aux patients avec des solutions logicielles de nouvelle génération comme Lightning Flash 2. 0, conçue pour l'élimination rapide des caillots sanguins et le traitement de l'embolie pulmonaire. Penumbra s'engage à améliorer les résultats pour des conditions telles que l'AVC, l'anévrisme cérébral et l'infarctus du myocarde, soutenue par des preuves cliniques et des stratégies de croissance des investisseurs.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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).