Job Description Summary

Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. These tasks are to be performed independently or team based with minimal guidance and supervision

 

Job Description

Major accountabilities:

• Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output.
• Translate business requirements into logical models and provide direction to the development team to translate business logic.
• Lead authoring of the user requirements document, functional specifications and functional testing scripts
• Proactively identify or address needs for optimal data review working with users and programmers as appropriate.
• Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner
• Provide coordination between the project resources so that deadlines are met on deliverables.
• Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization.
• Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders
• Provide quantitative analytical support to the global program teams, including providing support on analyzing reports and defining KPI Metrics.
• Systematically sample / monitor utilization of reports and tools, perform and coordinate periodic review of outputs. Report findings and take necessary steps to ensure reports are being used for optimal data review via Metrics
• Create, file and maintain appropriate documentation
• Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data
• Lead initiatives within Analytics, including training, to support overall compliance and adherence to data review through robust reports and tools.
• Proactively identify and address areas of concerns to avoid issues and ensure consistency, accuracy and completeness of reported clinical data
• Support or lead special projects of limited scope (sub team lead, local project, etc.) both clinical and non-clinical in nature. Provide study level expertise and involvement in CTTs and on GPTs for small projects.

Minimum Requirements:

• At least 7-9 years’ experience in clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry as well as the following:
• Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, 
• SAS, Python, R) 
• Strong knowledge of Data Review and/or Business Intelligence tools 
• (such as Spotfire, JReview)

 

Skills Desired

Clinical Trials, Computer Data Storage, Computer Programming, Data Analysis, Data Structures, Programming Languages, Statistical Analysis