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SAS, Programmer, statistics, CDISC, SDTM, ADaM, CRO, clinical research, pharmaceutical, biotechnology, clinical data, data management, EDC, Electronic Data Capture, Medidata, Rave, Oracle, Inform, datasets, TLF, tables, listings, figures, programming, benefits, medical, dental, vision, 401k, Remote.
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Familiarity with Medidata RAVE and/or other clinical data management software preferred. Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews.
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Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS, familiarity with Rave and/or Veeva.
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5+ years of experience with SAS programming with clinical trial data. Piper Companies is looking for an experienced Senior Statistical Programmer (PK/PD) to join a well-established, global clinical research organization focused on improving the drug development process and access to therapeutics.
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Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. Experience working with Veeva Vault, Medidata Rave EDC, SAS and similar systems a plus. This includes all global validated applications across the Clinical Development, Clinical Operations, Biostats, Regulatory, Drug Safety, and Pharmacovigilance business units.
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Knowledge of Java, SAS Programming, Rave EDC and EBS Architecture is preferredContact Information. Knowledge of Java, SAS Programming, Rave EDC and EBS Architecture is preferredContact Information.
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Computer experience with database, spreadsheet, and analysis software (i.e. Rave or SAS preferred); Computer experience with database, spreadsheet, and analysis software (i.e. Rave or SAS preferred.
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Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.
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Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system. Prepare, test and implement post production changes as per study needs while ensuring data integrity.
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Knowledge of Rave eDC (Medidata Solutions) is a preferred. Experience with SAS LSAF and Pinnacle 21 is a plus. Experience with coding and running SAS programs is required. Knowledge of Rave eDC (Medidata Solutions) is a preferred.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds. This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
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Provide statistical programming expertise in PKPD such as generating ADPC, ADPP and POPPK datasets & NCA TFLs. Assist in establishing standardized programming procedures and work instructions. Strong background working in a CRO or Pharmaceutical environment.
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Create eCRF specifications, design, develop and validate clinical trial setup in EDC. based employees are also eligible to receive, per calendar year, up to. Manage and oversee EDC system configuration, EDC Build, and integrations with EDC. Create and own database build SOPs and processes.
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As the Senior EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies. The EDC Engineer maintains and serves as an expert for implementation of EDC best practices and is expected be familiar with leading EDC technologies available on the market.
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