Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The Principal 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' phase I-IV clinical trials. The Principal DM Systems Programmer will actively search for solutions which reduce study set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.
The Principal DM Systems Programmer provides technical excellence to Data Management to standardize and streamline review and cleaning of data received through other routes than the EDC system by developing appropriate tools and data standards. The individual oversees and/or 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 Principal DM Systems Programmer has strong IT/systems background and experience, combined with breadth of experience through support of multiple drug development teams and customer stakeholders. The Principal DM Systems Programmer may represent Astellas in external industry collaborations and process improvement discussions, with a focus on networking discussions on best practices.
Essential Job Responsibilities:
- Leads and manages the study design and build life cycle.
- Assists and provides study level support to study teams and junior team members. Assesses complex technical or procedural issues, chooses among alternatives and facilitates resolution.
- 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.
- Seeks to make continual improvement to processes and templates used to create technical specifications.
- May develop complex reports using JReview, Business Objects, Crystal Reports, etc. Troubleshoots and resolves report issues.
- Oversees or acts as intermediate between Data Management, Statistical Programming and external data provider regarding external data specifications data and technical issues.
- Development and improvement of standards, templates, and process to improve efficiency and quality of databases/database setup is expected along with a level of technical expertise that evokes innovation.
- Oversees 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.
- 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.
- Helps end users understand the challenges before them, analyzes/understands the current state/process to ensure that the context/implications are understood by them and needs and expectations are represented correctly in the final solution.
- Has expertise to work with end users and technical teams with ease to translate user requirements into workable solutions using the available systems/technologies.
- 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.
- Works with data standards subject matter experts (SMEs) to ensure data transfer structures comply with Astellas' standard data models. Makes significant contributions, or may lead, the development and maintenance of external data standards and the processes needed to support their use and evolution.
- Oversees development of 8-12 outsourced studies per year and maintenance of 18-20 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 and number of External Data Specifications per study (1-15).
- Reports to Associate Director/ Director, DM Systems.
- Contributes subject matter expertise to study teams, as needed.
- Independent worker, working under loose supervision of Line Manager.
- Closely collaborates with cross-functional study team members (e.g., Data Manager, Study Manager, Clinical Programmer, etc.) or other cross-functional staff such as procurement, systems and IT staff as appropriate.
- Interacts with counterparts globally and is expected to provide focused support to all global DS team members, as driven by business need.