Astellas Pharma Data Mgmt Systems Principal Programmer in Northbrook, Illinois
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 Data Management Systems Programmer opportunity in Northbrook, IL.
Purpose & Scope:
- The Data Management 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 Data Management Systems Programmer will actively search for solutions which reduce 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.
- Development and improvement of standards, templates, and process to improve efficiency and quality of databases/database set-up is expected along with a level of technical expertise that evokes innovation.
- The Data Management Systems Programmer is assigned to support more complex study designs, high priority/pivotal studies or studies that require global data harmonization discussions.
Essential Job Responsibilities:
Performs the following study and system related activities:
- 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.
- Create and maintain programs and output (tables, figures and listings) using various of tools (J-review, Crystal reports, SAS, C++, Macros etc.). Troubleshoots and resolves report issues.
- May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations, testing and reports.
- Act as a reporting lead and providing oversight between vendors and Astellas team supporting reporting needs. Manages/Oversees the activities of CRO vendors for studies where data management systems work is outsourced.
- Collect and write input as well as output requirements.
- Write functional requirements.
- Coordinate and oversee code development.
- Coordinate proper test panels for User Acceptance Testing.
- Defines, communicates and enforces coding standards, identifies reusable code required for the Astellas code library. He/she ensures the high quality creation of the code. He/she tracks and identifies new opportunities to improve our methodology and training offerings.
- Provides governance/oversight to ensure deliverables adhere to Astellas and industry best practices and to ensure high quality output is delivered in line with agreed timeline.
- Maintains day to day contact with CRO staff to handle questions, help resolve issues and mitigate risks.
- Provides expert level technical direction to less experienced team members in order to ensure highest quality results.
- Conducts study and project lessons learned.
- Maintains all supporting documentation for studies/systems in accordance with processes to ensure quality, traceability and compliance.
- Leads discussions in global committees regarding database set-up, system configuration, system integration, eCRF/Global Library, edit checks, derivations, and reports as assigned.
- Understands and analyzes complex study team and other stakeholder needs with regard to data management systems, and leads teams through the process of identifying solutions to meet their needs.
- Specializes in one or more data management systems and is the single point of contact or subject matter expert for the system(s).
- 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 users to prioritize, rationalize and simplify requirements.
- May train department personnel and junior team members on new applications, process and reports.
- May be required to travel for project meetings and/or training purposes.
People Development /Management
- Provides guidance, advice and support to junior team members to provide best in class data management systems analysis, design and programming to support Astellas' drug development programs.
- Acts as leader and leads by example.
Performance and Resource Management
- Contributes to the development of metrics and key performance indicators (KPIs) for measuring and monitoring performance standards.
- Works to established timelines and key performance indicator goals.
- Provides study oversight and ensures that all Data Management Systems deliverables outsourced to CROs are delivered on time with quality.
- Provides new and innovative ideas regarding use of data management systems and/or processes that will improve efficiency, quality, and cost-effectiveness.
- Responsible for maintenance, development and implementation of best in class standards, processes, and standard operating procedures (SOPs) in regards to data management/data management applications/software tools.
- Stays abreast of industry development with regard to database programming, software tools, improvements and solutions that will improve efficiency in database build, data review and data cleaning.
- Responsible for adhering to quality standards and assisting other members of the team with adherence.
- Complies with established SOPs and Astellas, EMA, FDA, and ICH regulations and policies.
- Collaborates with Global Clinical Science, Global Clinical Pharmacology & Exploratory Development, Medical Affairs, Health Economics and Outcomes Research, CRO vendors, and study team members to enable collection and use of clinical data.
- Partners with the Data Manager and other study team members to plan for success of study deliverables.
- Interacts with Data Management, vendors and Global Development Operations (GDO) Business Information Systems Management group to provide technical support on applications used in Data Management.
- Collaborates with key stakeholders on change control and routine system maintenance.
- Collaborates with information technology groups and other key stakeholders in evaluating and implementing new technologies.
- Inspires individuals for project and study delivery, and provides expert input into development programs.
- 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.
The Data Management Systems Principal Programmer/Analyst will report to Data Management Systems Senior Manager Team Lead/Associate Director Data Management Systems.
- BS/BA degree in computer science. Combination of data management application experience and college courses in a related field may be considered.
- Generally 7-10 years of relevant programming experience, with at least 7 years in the pharmaceutical industry and at least two years' experience working with vendors
- 2+ years of experience in leading teams of programmers
- Excellent SAS programming skills
- Excellent understanding of SAS analytical tools (SAS/BASE, SAS/STAT and SAS/GRAPH)
- Demonstrated knowledge of computer system validation concepts, methodology and its application in a pharmaceutical environment
- Understanding of database theories
- Advanced knowledge of SQL
- Knowledge of the drug development, Software Development Life Cycle and Computer System Validation process.
- Strong computer skills required, including knowledge of programming, database management software.
- Advanced knowledge of programming languages (SQL, C#, C++, Java) as well as advanced knowledge of reporting and business intelligence tools like J-Review, Business Objects and Crystal Reports.
- Solid understanding of relational database structure.
- Demonstrated experience in leading system selection and implementation projects.
- Solid understanding of data flow.
- Good knowledge of systems outside of data management, like safety systems, Clinical Trial Management Systems and also electronic patient reported outcome tools.
- Excellent verbal and written communication skills and is capable of working with individuals across multiple disciplines, projects, and regions.
- Have strong technical and significant experience in developing scalable process/solutions.
- Strong organizational skills and ability to prioritize work for self and others to ensure timelines are met.
- Demonstrated interpersonal and project management skills.
- Must be proficient in Microsoft Office Suite
- Preferable knowledge of at least one programming language other than SAS (for example Visual basic, C++). Preferable knowledge of at least one web-development language (for example JAVA, C#, HTML).
- Ability to manage activities of multiple technical projects and provide training.
- Ability to learn new technologies quickly and disseminate information.
- Ability to improve existing approaches by seeking opportunities to creatively transform current industry practices into fresh alternative solutions.
- Ability to provide SME-level support/training and/or mentor/coach team members.
- Ability to effectively lead discussions regarding best practices and facilitate value-added input from other team members.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Data Science