AbbVie Statistical Analyst in Lake County, Illinois

Description:

The Statistical Programming group is a part of Data and Statistical Sciences (DSS) and is responsible for providing statistical programming services to the Global Pharmaceutical Research and Development division (GPRD). These services are supplied in the context of a cooperative and project-oriented effort with the Global Project Teams (GPTs) and Product Safety teams (PSTs) in the summarization and reporting of data from clinical trials. These services also include the summarization of aggregate data and creation of submission documents to be provided to regulatory agencies. We have an exciting opportunity for a Senior Statistical Analyst or Statistical Analyst based in North Chicago, IL reporting to the Senior Manager, Statistical Programming.

Key Responsibilities:

  • Provide statistical programming support for multiple clinical projects or therapeutic areas

    TABLES, LISTINGS, GRAPHS, NARATIVE, ETC. CREATION

    SAS Programming:

  • Demonstrated extended understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry and ability to apply SAS programming knowledge to solve problems related to non-routine situations

    Consistency:

  • Ensure internal consistency of output and assess consistency with other activities for the project, as applicable

    Standards:

  • Contribute to the determination of project standards related to output design and statistical programming conventions and independently ensure they are appropriate to support project objectives

    Validation of SAS Programs:

  • Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities

  • Responsible for determining the scope of the peer review and for ensuring peer review has been completed for all activities for the assigned projects

    Archival of SAS Programs:

  • Ensure all SAS programs are imported into the archive system prior to the creation of final output

  • Ensure all programs are formally archived after the completion of the regulated activity

    DATABASE ACTIVITIES

    Derivation Programming:

  • Demonstrated proven ability to interpret statistical analysis plans to develop analysis data set specifications

  • Responsible for the creation and accuracy of derivation programs for routine and non-routine situations
  • Responsible for ensuring peer review has been completed for all derivation programs for assigned projects

    Data Integration:

  • Responsible for the creation and accuracy of integrated data sets

  • Responsible for the creation and review of integrated data set specification
  • Responsible for ensuring peer review for all integrated data sets and programs for the assigned projects

    Data Standards:

  • Demonstrated understanding of CDISC SDTM and ADaM standards

  • Demonstrated understanding of submission data requirements

    Submission Data Sets and Programs:

  • Responsible for the creation and accuracy of submission data sets and analysis programs for routine and non-routine situations

  • Responsible for the creation of data definition documents
  • Responsible for ensuring peer review for all submission data sets and programs for the assigned projects

    PROCESSES, UTILITIES AND MACROS

    Unix Utilities :

  • Maintain expertise in the use of the UNIX utilities

  • Independently develop new UNIX utilities
  • Responsible for formulating proposals for new utilities, as well as, presenting information on existing utilities

    Process Improvements:

  • Responsible for identifying opportunities for productivity improvements and formulating implementation plans

  • Independently develop new processes

    SAS Macros:

  • Maintain expertise in the use of the SAS Macros. Independently develop new SAS Macros

  • Responsible for formulating proposals for SAS Macros, as well as, presenting information on existing Macros

    CONSULTATION

    Teamwork :

  • Work collaboratively with others to develop quality CRFs, databases, reports, publications and regulatory submission

    Client interaction:

  • Provide accurate and timely responses to routine requests from clients

  • Guide clients on possible options for deliverables for non-routine requests
  • Responsible for developing and maintaining good client relationships
  • Effectively represent the Statistical Programming organization on cross functional initiative teams

    Communication:

  • Clearly communicates an understanding of statistical programming concepts, basic clinical principles, and regulatory standards, and acts in accordance with those principles

    GPT Involvement:

  • Represents the Statistical Programming Organization on Study Teams and be adhoc participant on PST teams

    TRAINING, MENTORING, SUPERVISING, PROJECT COORDINATION

    Training and Mentoring:

  • Be compliant with training requirements

  • Effectively mentor non-statistical programming peers with regard to statistical programming practices
  • Effectively mentor statistical programming and non-statistical programming peers with regard to functional operations
  • Train new statistical programmers on statistical programming practices

    Project Coordination:

  • Coordinate the statistical programming activities for 1-4 clinical projects within or across therapeutic areas

  • Oversee the work of 0-5 Statistical Programmers/Senior Statistical Programmers or contractors
  • Appropriately delegate assignments and reviews deliverables so that projects are delivered on time with suitable quality

Qualifications:

For Statistical Analyst:

  • MS in Statistics, Computer Science or a related field with 3 years of relevant experience OR BS in Statistics, Computer Science or a related field with 5 years of relevant experience
  • High degree of technical competence and communication ability, both oral and written
  • Competent in SAS programming and Macro development
  • Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA

    Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance

Job Classification: Experienced
Job: INFORMATION TECHNOLOGY
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1607814

Equal Opportunity Employer Minorities/Women/Veterans/Disabled