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Statistical Programmer II (Office/Home-Based) - Iqvia Biotech (R1069953) in Morrisville, NC at IQVIA™

Date Posted: 4/13/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    4/13/2019
  • Job ID:
    R1069953

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

BASIC FUNCTIONS:

Perform lead responsibilities on one or more projects.  Develop and validate programs to generate data cleaning reports and prepare data extracts. Provide programming support to project team members and others within Project Programming.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Perform as a SAS Data lead for projects
    • Draft, update and maintain the Master Plan for assigned project and review study plans for other departments.
    • Review and provide feedback on project timelines and ensure that project tasks are completed timely and with acceptable quality
    • Manage study sFTP site accounts
    • Assume responsibility for project budget, and perform monthly time projections.
    • Attend internal team meetings and relevant client team meetings, as needed.
    • Review data transfer specifications and test transfers from external vendors as applicable for reconciliation purpose.
    • Review and provide/collect SAS feedback on eCRF development and data structure changes and evaluate the impact on programming activities
    • File documentation associated with client delivery on an ongoing basis, and perform final archival activity at study close.
  • Manage and support project programming activities and deliverables
    • Develop specifications/test data and program custom data files, SDTM and data integration as requested by Sponsor; update blank CRFs with SDTM or other custom annotations, develop define.xml file for SDTM.
    • Set up default clinical data transfer and/or perform scheduled and ad-hoc data transfers
    • Define specifications/test data, program and generate reports to facilitate vendor and/or SAE reconciliation, medical coding, investigator payments, data review (e.g., SAS data checks and patient profiles) and other needs, as requested.
    • Define specifications and test plans for data imports.
    • Develop specifications and programs to integrate local lab normal ranges with data extract.
    • Set up project-specific J-Review system for InfoLink and/or InForm.
    • Support programming activities for medical coding group, including integration of coded terms with data extract files.
    • Develop QC test plans, perform independent  unit testing, complete documentation for SAS code installs and utilize source code management software.
  • Project Programming departmental responsibilities
    • Assist with process improvement initiatives, as agreed to by management.
    • Perform other duties that may be requested by management as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Knowledge of programming and validation methods, and software development life cycle.
  • Knowledge of relational database concepts, and SQL experience.
  • Experience with SAS Base, SAS Macro, and ODS as well as strong data step skills.
  • Ability to perform multiple tasks efficiently and accurately with minimal supervision while meeting deadlines.
  • Ability to work independently and part of the team.
  • Ability to learn new programming languages, technology, tools and processes.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

  • BS degree (or equivalent, based upon education and experience) in Computer Science, Mathematics,  life/analytical sciences or related field, and 2 years of work experience in SAS programming, preferably in a clinical environment, or
  • Masters-level degree in Computer Science, Mathematics, life/analytical sciences or related field with a minimum of 1 year of work experience in SAS programming, preferably in a clinical environment.
  • Excellent communication, interpersonal, and organization skills, highly detail-oriented.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1069953