penumbrainc - Clinical Data Analyst II
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 processes and workflows to support reproducibility • 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. • Further programming and reporting skills independently • 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 science, or related field with 2+ years of experience, or equivalent combination of education and experience • Solid hands-on knowledge of at least one programming language (e.g., Python, SAS, R, MATLAB, C Sharp, Visual Basic, SQL) required • Master’s degree preferred • Experience in the analysis of medical or scientific data is strongly preferred • Relational database experience preferred. • An understanding of the software development lifecycle process is preferred. • Experience with clinical database (e.g., Medrio, InForm, RedCap, OpenClinica, Medidata RAVE) a plus. • Knowledge of core clinical data management applications (Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite) a plus.
Responsibilities
• Collaborate with clinical project 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 specification, programming and testing of risk-based monitoring reports, complex cross-form data cleaning reports, and integrations between systems. * • 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 study team by choosing the right programming technique and software tool for each problem. * • Independently program reports to execute trial-specific data review/cleaning plans • Design, write, and maintain code to perform complex data transformations, including data import/export, transposition, and ETL processes; ensure accuracy, efficiency, and reproducibility. * • Integrate data from multiple systems to create reports and dashboards that meet the clinical study needs. • Automate routine data processing and reporting tasks to improve efficiency and reduce manual effort • Write, validate, and optimize analytical programming scripts and report specifications • Assist in the setup 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 build and testing of clinical study databases, by defining study requirements specifications for data validations with minimal supervision and accurately conducting testing of the data validations. * • Participate in and contribute to project discussions. Communicate 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 considering 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 communication skills • Proficiency with MS Word, Excel, and PowerPoint • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously • Working Conditions • General office environment. • 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. • Working Conditions
Benefits
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
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