$80K — $100K *
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Data Management Systems Programmer opportunity in Northbrook, IL.
Position & Scope:
The Senior Data Management (DM) Systems Programmer develops, manages and supports data management (and related) systems (e.g., EDC, reporting and visualization tools, coding tools) used to collect, review and clean data in Astellas's phase I-IV clinical trials. The Senior DM Systems Programmer is assigned to support more complex study designs, high priority/pivotal studies or studies that require global data harmonization discussions.
The Senior DM Systems Programmer participates in global harmonization activities as related to building study databases and applies advanced knowledge in the programming of complicated validation checks, intermediate to complicated reports and system interfaces.
The Senior DM Systems Programmer provides technical expertise and support to Data Management to standardize and streamline data checking and data cleaning of data received through other routes than the EDC system by developing appropriate tools and data standards. Provides technical support to Data Management and/or CRO to collect and check data received from external providers (e.g., central laboratories, ECG laboratories, and Biopharmaceutical laboratories). The Senior DM Systems Programmer provides specifications and creation of programs to check and ensure consistency between data received from external data providers and (e)CRF.
Essential Job Responsibilities:
· Creates, reviews and approves technical specifications for data management systems. Develops complex programs and/or technical solutions per technical specifications.
· Supports database build activities (e.g., eCRFs, change requests, edit checks, special actions/functions, derivations, interface configuration) as needed and troubleshoots study build issues and/or system integration issues.
· May develop intermediate to complex reports using JReview, Business Objects, Crystal Reports, etc. Troubleshoots and resolves report issues.
· Seeks to make continual improvement to processes and templates used to create technical specifications.
· Manages/Oversees the activities of (CRO) vendors for studies where data management systems work is outsourced.
· Partners with the Data Manager and other study team members to plan for success of study deliverables.
· Creates and maintains standard specifications and standard programs/macros for external data vendors (e.g., central lab, PK, ECG). Defines specifications to automate reconciliation (i.e., create functional requirements for standard macros) and to create SAS programs to perform external data checks against the data transfers received for data reconciliation.
· Provides clean external data as SAS datasets as required by Statistical Programming for statistical analysis.
· Responsible for the implementation and maintenance of assigned data management systems and all associated processes and standards to support and improve them.
· Works with SAS programmers and electronic data capture (EDC) programmers, as well as external data vendors to design, build and implement interfaces between the external data vendor's systems and SAS or external data collection applications (e.g., ePRO) and SAS to further standardize and facilitate external data reconciliation.
This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Employees holding this position may perform other job-related duties in the course of their performance of this position
· Oversees development of 5 -- 10 outsourced studies per year and maintenance of up to 15 outsourced studies per year.
· May build 2-3 studies per year.
· For external data support, this individual provides technical support to Data Management for 1 -- 6 studies depending on the status of each study.
Valid through: 8/27/2020