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
Support 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.
Produce and track reports 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.
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.
Program reports of various complexity from documented requirements, within the clinical reporting
systems using SQL, PL/SQL, C#, VB script, SAS, Python, R.
Good Knowledge of Novartis Clinical Data Standards and its implementation for creation of
reports specifications or reports output.
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
At least 4 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)
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
Ability to translate technical concepts for non-technical users in the areas of clinical database design and data review reporting development
Strong verbal and written communication skills to work with our global partners and customers
Understanding of Drug Development Process, ICH-GCP, CDISC standards and Health Authority guidelines and regulations
Ability to train and supervise new or less experienced associates
