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Statistical Programmer 2, Global BIOS

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1243713

Descripción del trabajo

Join us on our exciting journey!

The Global Biostatistics (Data Sciences, Safety & Regulatory) team at IQVIA are experienced in submissions for all major regions; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing, to drive efficiency and accountability.

We have one of the largest Biostatistics departments within the industry of around 1,100+ staff, to which we engage the full range of industry-leading resources and expertise spanning all study phases and therapeutic areas.

Due to continued growth, we are seeking new brave minds to join our award winning and innovative department. You will have the opportunity to work globally and across a variety of therapeutic areas. 

IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting.

Job Overview:

As a Statistical Programmer 2, you will be given access to cutting-edge, in-house technology and opportunities to work on global projects across a variety of therapeutic areas. Thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose. You will also provide advanced technical expertise to develop and maintain programs to meet internal and external clients’ needs. You will plan and lead the development of project-related solutions to the full scope of statistical programming tasks. As a lead programmer on assigned studies, you will write and maintain programming specifications datasets and program TLFs, to maximize programming efficiency with the use of biostatistical tools and assist in training and mentoring new or junior team members

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:

  • Bachelors or Masters’ in Computer Science, Mathematics or equivalent

  • 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

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

What is in it for you?

  • Global exposure

  • Variety of therapeutic areas

  • Collaborative and supportive team environment

  • Access to cutting-edge in-house technology

  • Excellent career development and progression opportunities

  • Work-Life Balance

  • Home-based with no travel requirements

JOIN US

Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do!

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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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