Systems Analyst II

Seeking a Systems Analyst (internally referred to as SAS Programmer) to Create, maintain and test code used for non-standard data file creation as well as for CDISC SDTM and ADaM datasets; mentor System Analyst I staff; programming resource for Clinical Data Operations staff and other departments as needed including creation of statistical and submission-ready datasets.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Attend client meetings as appropriate to understand data collection requirements for the protocol.
• Receive and review standard Clario / non-Clario standard client file specifications from Data Manager / Project Manager or client and interact with the client to finalize transfer specifications.
• Develop and validate programs to create non-standard data files as well as CDISC SDTM and ADaM compliant datasets.
• Create submission-ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) including define.xml and dataset reviewers guides for FDA submissions.
• As part of the Software Development Life Cycle, develop and unit test code, create and execute test scripts and perform peer review.
• Process data extracts, review encoding requests daily to run encoding programs and archive studies.
• Performing ad-hoc programming activities utilizing raw data based on internal and external requests for :
• Esoteric quality control checks.
• Data resolution / mining.
• Treatment emergent flags and other specifications per Statistical Analysis Plan.
• Other client requirements.
• Work with data management in providing programming support for DM activities including data review.
• Prepare and participate in internal and external audits.
• Work across multiple service lines and modalities.
• Work hand in hand with a cross functional teams (Cardiologists, Data Managers, Project Managers and other industry experts) for project delivery - for example to support New Product Initiatives and Minimum Viable Product solutions.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
• Contribute to the development of best practice to improve quality, efficiency and effectiveness.

OTHER DUTIES AND RESPONSIBILITIES :

QUALIFICATIONS AND SKILLS NEEDED :

Education  :

Experience  :

Skills Required

Sql, Python, Data Analysis, System Design, Api Integration, Agile Methodologies