Under minimal supervision of the Manager of Clinical Data Management or higher, the Clinical Data Analyst II T selects the appropriate data sources to develop reports and dashboards of clinical data.
Working in collaboration with statisticians, data managers, clinical research staff, IT, and quality assurance staff, the Clinical Data Analyst II will provide clinical data analysis reports and tools that enhance operational processes.
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.
Participate in audits as required.
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.

Requirements

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.
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.
Able to take initiative on own project responsibilities
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.

Benefits

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).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

PythonSASRMATLABC SharpVisual BasicSQLETLdata visualizationdashboarding

Soft Skills

attention to detailmulti-taskinginitiativeinterpersonal communicationoral communicationwritten communicationmentoringprocess improvementcollaborationproject management