Job Description Summary

Participate in the full lifecycle of producing key data and/or complex reports/visualizations for multiple global clinical studies 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.

 

Job Description

Major accountabilities:

• Produce and track reports, analytics or visualizations for various line functions within Global Drug Development, used for ongoing monitoring of clinical data
• Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders
• Author the user requirements document, functional specifications and functional testing scripts
• Facilitate interaction with end-user on creating specifications and working with programmers or performing the programming activities for successful delivery.
• To provide quantitative analytical support to the global program teams, including providing support on analyzing reports
• Support the planning, execution and close-out of Clinical Programs/Trials.
• Support the management in collation and delivery of analytics reports for critical decision making
• 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
• Provide necessary training to end-user on best / appropriate and consistent use of various data review tools
• 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.
• Lead or provide support to special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues, processes, user support, training, etc.

Minimum Requirements:

• At least 6 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:
• Excellent knowledge of programming languages (SQL, PL/SQL, 
• C#, VB script, SAS, Python, R) 
• • Excellent knowledge of Data Review and/or Business Intelligence tools (such as Spotfire, Review)
• Knowledge of clinical data management systems and/or relational databases (e.g. OC/RDC, INFORM, RAVE) as applied to 
• clinical trials 
• Attention to detail, quality, time management and customer focus development. Understanding of Drug Development Process, ICH-GCP, CDISC standards and Health Authority guidelines and regulations.

 

Skills Desired

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