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Astellas Pharma Senior Data Management Systems Programmer in United States

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.

Quantitative Dimensions:

  • 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.

Organizational Context:

  • 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 collaborate with other global DS team members, as driven by business need.

Qualification

Required

  • BS or MS degree in Computer Science, Informatics, or life science discipline; minimum of 4 years in pharma or CRO industry in an informatics or programming role.
  • Experience using SAS, ORACLE and SQL is helpful.
  • Experience using Crystal Reports, Business Objects and other business intelligence tools is helpful.
  • Demonstrated competence in DM systems, inclusive of all activities from study start-up to DB Lock.
  • Solid understanding of relational database structure.
  • Demonstrated experience using Medidata Rave (or similar EDC system) from a front end data management user perspective. Back end user knowledge of Medidata Rave is desirable.
  • Good cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical, with high level of expertise expected in the DM systems discipline.
  • Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
  • Excellent verbal and written communication skills.
  • Proven ability to work with and influence individuals across multiple disciplines in international environment.
  • Solid project management and organizational skills in order to prioritize work for self and others to ensure timelines are met, oversee activities of multiple studies.
  • In-depth knowledge of the drug development and data management processes.
  • Very good knowledge of international regulations for clinical trials (e.g. GCP).
  • Ability to communicate effectively and maintain effective relationships. Must be able to influence staff in other Astellas groups.

Salary Range

$115,500 - $154,000

Top benefits including:

  • Medical, Dental and Vision insurance
  • Generous Paid Time Off options, including Vacation and Sick time, national holidays and year-end holiday shutdown
  • 401(k) Match and Annual Company Contribution
  • Company Paid Life Insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Annual Financial Wellness Allowance and Annual Wellness Reward
  • Long Term Incentive Plan for eligible positions
  • Referral bonus program

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Data Science

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