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Statistical Programmer II

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Primary Location: Durham, North Carolina, United States Additonal Locations: Boston, MA,USA; Chicago, IL,USA; Dallas, TX,USA; Kansas City, KS,USA; Miami, FL,USA; New York, NY,USA; Portland, Oregon, United States,USA; Seattle , WA,USA Full time R1236965

Job description

Join us on our exciting journey!

From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues. 

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity, and intellectual courage every step of the way.

We have one of the largest Biostatistics departments within the industry of around 1,100+ staff. Due to continued growth, we are seeking new brave minds to join our team.

Job Overview:

To provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs.

Plan and lead the development of project-related solutions to the full scope of statistical programming tasks.

Provide technical expertise to the Statistical Programming department.

Key Responsibilities:

  • Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution

  • Datasets: Writes and maintains programming specifications datasets. Programs assigned datasets to industry standards. Handles dataset derivations and assignment

  • Tables, Listings and Figures (TLFs): Programs TLFs, maximizes programming efficiency with use of biostatistical tools. Checks resulting output for format and content, and questions specification as needed.

  • Leadership: Perform as lead programmer on assigned studies. Through this, works closely with the Biostatistical Team Lead and Supervisor, to deliver on time, with high quality and within budget. Tasks include but are not limited to:

  • Develops an efficient programming strategy utilizing available tools and creation/ maintenance of project specific macros, ensures compliance with Good Programming Practice as per SOPs.

  • Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions.

  • Actively participates in internal project team meetings, provides timely progress updates.

  • As a lead, will have input on estimate at completion (EAC) reporting

  • Timelines: Plans and documents timelines and forecasts resource needs

  • Project Programming Set Up: Programming project set up and maintenance of BIOSETUP, global tools & project macros

  • Programming project set up for integrated databases, with supervision

  • Statistical Analysis Plan (SAP) and Shells: Performs programming review of SAP and shells, where applicable. Writes programming specifications/shells for safety outputs

  • Financials: Shares accountability (with resource managers) of the financial success of their studies

  • Responsible for sharing budget expectations with their team.

  • Understands 'scope of work' and has an awareness of contract and budget assumptions

  • Knowledge Sharing: Helps train staff regarding operational items and mentor’s junior staff

  • Risk Management: Proposes solutions to mitigate risks.

  •  Other CDISC requirements: Reviews Pinnacle 21 output and resolves issues. Creates or performs quality control (QC) review of define.xmls, SDTM and/ or ADaM reviewers guide (SDRG, ADRG), under supervision as needed.;

  • Perform lead programmer role on studies

  • Proposals: Review and comment on proposals/budgets at a study level

  • Present at bid defense meetings

  • Customer: Serve as primary point of contact for customer and consult on operational topics with clients.

Requirements:

  • Degree in Mathematics, Statistics, or related field

  • 3+ years, statistical programming experience within the Life Science industry

  • Experience as project lead directly engaging clients and coordinating tasks within a programming team

  • Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

  • Knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language

  • Ability to independently lead multiple tasks and projects and to delegate work to other members of the SP team

JOIN US

You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately, improve outcomes for patients.

Whatever your career goals, we are here to ensure you get there!

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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