• Safety Data Analyst SAS / Senior Safety Data Analyst SAS

    Job Locations US-NJ-Jersey City
    ID
    2018-1200
    # of Openings
    1
    Category
    Drug Safety
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

     

    Manages Drug Safety Data Systems to ensure the timely creation, deployment and maintenance of databases required by MTDA projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design data entry interfaces in accordance with SOPs, client requirements, and regulatory guidelines.

     

    Provides technical support for the Drug Data Systems employed in processing and management of study safety data encompassing reporting tools for data review and Drug Safety metrics, performance and quality, generation. Resolves Drug Safety data integrity issues and addresses database design inconsistencies over time. Manages and monitors interactions with Drug Safety project specific third party vendors. Identifies process optimization to improve efficiencies. Develops and maintains standard library (global, therapeutic and client specific). Provides technical support to the Global Drug Safety Data Management staff and Project Team for existing databases, user interface, reporting tools, metrics generation and E2B / CDISC standards.

     

    This will be a three month renewable contract position.

    Responsibilities

    • Deploy complete, accurate and efficient database(s) for the purpose of Drug Safety Data Management and Data Processing. To conduct and support design and programming of data entry interface, data structures and quality rules for assigned projects and studies.
    • Support and ensure the preparation, transfer and integration of safety data from internal and external sources into the database.
    • Provide safety data in various formats and applications to Drug Safety data management customers.
    • Ensure high quality deliverables, good cooperation with internal and client partners and active participation in project teams.
    • Setup of Drug Safety Data Management tools for study conduct. (e.g., data quality checks, validity tool, coding call, SAE, etc.)
    • Full Drug Safety study programming and validation responsibility - Develop, program, test and maintain computer edit/validation checks.
    • Develop programs for transformation of the acquisition of drug safety data from the ‘core’ Data Systems to a definitive study database to meet MTDA / client project standards.
    • Ensure in conjunction with Drug Safety Data Project Manager adherence to MTDA standards and validation of all study related calculations and data mappings.
    • Full responsibility for safety data exchange with external parties, for example, client, third party vendors (Labs, ECG, etc.) and Safety / Independent Data Monitoring Committees.
    • Provide ongoing day to day end-user support to the US Drug Safety team to ensure all drug safety systems and programs are executing correct and efficiently.
    • Setup and support of data review and reporting tools required by stakeholders in Global Drug Safety, Clinical, Medical, and Regulatory Affairs and where required Client Study Management Team.
    • Provide technical expertise and programming support for MTDA projects and safety data management staff.
    • Communicate project status and key project issues to Drug Safety Data Manager.
    • Assist in developing new Drug Safety Data Systems programming procedures and processes.
    • Keeps current with technological advances and coordinates activities with Global Training and Information Technology Team in an effort to maximize their potential use in managing data.
    • Provide mentoring and training of others.
    • Assist in delegating work.
    • Run and review Drug Safety department metrics, plus perform some root cause analysis.
    • Manages Drug Safety Data Systems  and support projects at MTDA with special attention to the administration and evaluation of Drug Safety Data Systems including but not limited to Global Safety Database, Query Tool, CDMS, EDC, Clinical and Regulatory Systems,  ensuring that all submission safety data are captured and stored in a validated environment consistent with 21 CFR part 11.
    • Supports, maintains and utilizes standardization of electronic modules, data quality rules, data structures, data libraries, code lists, and dictionaries in conjunction with input from other functional areas and project teams and in accordance with E2B / CDISC standards.
    • Provides technical expertise to project teams in the operational aspects of Drug Safety Data Systems and support, ensuring consistency among systems to avoid redundancy, inefficiency, or potential problems; and keeps current with technology trends as they affect data systems management.
    • Manages and coordinates activities of Drug Safety vendors through the project cycle of all studies from study start up to archival ensuring adherence to MTDA procedures and policies.
    • Provides training in use of systems, including but not limited to ARISg Safety, ARGUS Safety, Oracle / Clinical and EDC, as well as, the application and use of electronic modules, data quality rules, data structures, data libraries, code lists, and dictionaries to other functional areas and project teams.
    • Manages and coordinates external vendors’ activities ensuring their adherence to contract specifications.
    • Manages and coordinates the integration / consolidation and archival of drug safety databases in accordance with applicable MTDA, client and / or regulatory guidelines.
    • Evaluates external vendors and technologies as to their ability to perform in accordance to MTDA goals, procedures, and quality standards prior to contract finalization.
    • Identifies areas of process improvement that may be provided by standardization and/or technology to increase efficiency, quality and timeliness of safety data management processes and deliverables.
    • Provides Drug Safety metric reports for monitoring the progress of projects and processes for reporting to management and project teams.

    Qualifications

    • BA/BS in a life or Computer Science, Master's Degree in Science, Biological or Computer Science preferred or a combination of education and experience.
    • 3 to 5 years of experience in SAS programming in Clinical Data Management.
    • Expert in Global Drug Safety databases, or Oracle Clinical, SAS, SQL.
    • Expert in Query Tools, electronic data capture system(s) such as Spotfire, Business Objects, Crystal Reports, InForm, Rave, Cognos.
    • Strong experience in using data management technologies (clinical data management systems, electronic data capture, data review tools, data warehousing).
    • Experience in developing drug safety data management standards.
    • Ability to apply 21 CFR Part 11 standards to Drug Safety Data System deployment.
    • Demonstrate knowledge in research design, system validation, CDISC, standard coding dictionaries (MedDRA), ADaM and SDTM
    • Experience with regulatory submissions (e.g. BLA, NDA, NDS, MAA, etc.)
    • Experience managing vendors
    • Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
    • Strong communication, presentation skills, critical thinking skills, ability to set priorities and develop strategies/studies to answer complex research questions, solid problem-solving abilities.
    • Ability to work effectively in a cross-functional, project team environment and manage several ongoing projects
    • Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans).

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