Senior Report Programmer/Senior Clinical Programmer

2 weeks ago

Hyderabad, India Cytel Full time
At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Senior Clinical Programmer/Senior Report programmer role to develop listings and BO/J-Review Reports for various line functions, used for ongoing monitoring of clinical data.
Peer/technical review clinical programming activities:
Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. Facilitate interaction with end-users 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 in analyzing reports. Support the planning, execution, and close-out of Clinical Programs/Trials.
Support the management in the 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-users on the 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, C#, VB script, SAS, Python, R. Good Knowledge of Clinical Data Standards and its implementation for the 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.
Ensure all work performed is of high quality, and compliant with Good Clinical Practice, ICH Guidelines, and all applicable laws and regulations.
Ensuring all mandatory courses are completed before the designated date and that the required system-specific training has been completed for current studies.
Record all billable and non-billable time in the appropriate timesheet management system.
EXPERIENCE, SKILLS, KNOWLEDGE
Minimum 5 to 8 years of experience in data review, report development, and business intelligence tools.
Strong knowledge of programming languages (SQL, C#, VB script, SAS, Python, R).
Strong knowledge of Data Review and/or Business Intelligence tools such as Elluminate, J Review, and Business Objects. Preference for candidates with Elluminate tool experience.
Knowledge of clinical data management systems and/or relational databases(e.g. OC/RDC, INFORM, RAVE) as applied to clinical trials.
Ability to translate technical concepts for non-technical users in the areas of clinical database design and data review reporting development and assist in data visualization.
Understanding of the Drug Development Process, ICH-GCP, CDISC standards, and Health Authority guidelines and regulations.
Ability to train and supervise new or less experienced associates.
Prior relevant clinical research industry experience with excellent interpersonal, written and oral communication skills.
Excellent accuracy and attentiveness to detail and capability to work within a team environment.
Knowledge of regulatory guidelines in relation to data quality and clinical trial conduct.
EDUCATION REQUIREMENTS:
Bachelor or Master in Life Sciences, Clinical Data Management, Computer Science, Medical Informatics or equivalent degree.

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