penumbrainc - Clinical Data Analyst II - T
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Requirements
• Provide support to senior and manager-level clinical data analysts as needed. • Mentor and support less experienced clinical data analyst staff, peers, and other department staff. * • Proactively provide process improvement feedback to management and provide input in SOP and standards updates/development. • Maintain and continue to gain a broad overall knowledge in the field of clinical data analysis and clinical data management. • Responsible for attending training classes and professional meetings as required. • Create training materials for clinical users and developers • Document data sources and data mapping. • Create analytical data models and tools to help empower clinical teams • Follow data standards policies, procedures, practices, and regulations for clinical data analysis reports and tools throughout the process of collection and submission of clinical data. • Develops skills and shares them with others. • Provide technical support and training on reports and tools for clinical staff. • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * • Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned. • Indicates an essential function of the role • Bachelor's degree in mathematics, computer science, economics, life sciences, or related field with 2+ years of experience, or equivalent combination of education and experience • Master’s degree preferred with 1+ years of experience in data visualization, dashboarding or analytical report programming experience. • Solid hands-on knowledge of at least one programming language (e.g., Python, SAS, R, MATLAB, C Sharp, Visual Basic, SQL) required. Experience in the analysis of medical or scientific data is preferred. • Proficiency with Python or another equivalent programming language (SAS, R, SQL) with the willingness to learn python • Worked with visualization tools like Tableau, PowerBI, QlikSense, Spotfire • Experience eliciting and documenting specifications for reports, dashboards, or other tools • Experience performing programming verification • Relational database experience preferred. • An understanding of the software development lifecycle process is preferred. • Experience working for a sponsor on clinical trials • Experience using Veeva CTMS and reporting out of Veeva CTMS • Experience with ETL pipelines (Extract, Transform Load) • Experience performing UAT (User Acceptance Testing) for study builds in an EDC (Electronic Data Capture) • Experience with one of the following EDCs: Medidata, Medrio, InForm • Preferably Medidata • Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite) a plus. • Preferably Medidata
Responsibilities
• Collaborate with the clinical team to clarify and finalize user requirement specifications for clinical data analysis tools and reports. Communicate with selected vendors and/or build reports and / or tools to meet clinical user requirements. * • Lead technical projects like the development of risk-based monitoring programs, complex reporting and cross-form query building outside EDC, integrations between EDC and other systems, and data warehouse projects. * • Contribute to the development and maintenance of the data warehouse used to manage libraries of clinical study data including image, source document, and data files. • Develop dashboards and reports to support the clinical team by choosing the right technique and software for each problem. * • Independently develop reports to execute trial-specific data review/cleaning plans • Perform complex programming such as data import/export and data transposition (Extract-Transform-Load (ETL) accurately. Use advanced procedures and options. * • Assist in the setting up of programming timelines and deliverables for projects as required. • Assist in addressing external application vendor issues, integrations, and implementations. • Provide support for implementation of upgrades and new modules of remotely hosted vendors, acquiring all necessary documentation. * • Partner with organizational stakeholders to create and implement data analytics best practices • Contribute to the building and testing of clinical study databases, by defining study requirements specifications such as data validation specifications and participating in User Acceptance Testing (UAT) as needed. • Participate in and contribute to project discussions. Communicates with team members on a regular basis. • Utilize reports and data collection technology to identify possible data errors and questionable data trends • Excellent attention to detail and ability to multi-task taking into account established project priorities are essential • Demonstrated expertise in use of required technology • Medical device, pharmaceutical, biotech, or other regulated industry experience desired • Strong oral, written and interpersonal communications skills required • Proficiency with MS Word, Excel, and other standard office tools • Working Conditions • General office environment. • Willingness and ability to work on site. • Potential exposure to blood-borne pathogens. • Requires some lifting and moving of up to 15 pounds. • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. • Base Pay Range Per Hour: $38.00 - $55.00 • Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location. • Working Conditions
Benefits
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
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