IQVIA
life sciences and healthcare
Biostatistician/StatisticalProgrammer
“Biostatistician / Statistical Programmer at IQVIA. Skills: Biostatistics, Statistical Programming, Data Management, Statistical Analysis. Design study specific Common Data Models. Manage and harmonize raw data”
What You'll Achieve.
Production of High-Quality Deliverables; deliver on time, with high quality and within budget
Industry & Context.
follow issues to appropriate resolution; Handles data issue resolutions; Ability to solve moderately complex problems
What They're Looking For.
Must Have
Bachelor's Degree Biostatistics or related field, 1 - 3 years relevant experience, Master's Degree Biostatistics or related field, Ph. D. Biostatistics or related field, intermediate level knowledge of principles, theories, and concepts of a job area, applicable clinical research regulatory requirements, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, working knowledge of R computing package
Nice to Have
Familiarity with other relevant statistical computing packages such as SAS
What You'll Do.
Design study specific Common Data Models
Manage and harmonize raw data
Prepare quality checks
Write detailed specifications
guidance and mentorship
Produce High-Quality Deliverables
Conduct validation requirements
Check programming logs
Input into Data Issues log
Perform data management lead role
Build and maintain customer relationships
Drive data quality discussions
Support or guidance for data enhancement
Participate in project team meetings
Provide progress updates
Assist in reviewing database design
Handle data issue resolutions
Handle lock and unblinding process
Perform quality control review of SAPs
Make best use of resources
Author or QC complex SAPs
Write and maintain programming specifications
Program assigned datasets
Handle dataset derivations
Write programming specifications for outputs
Maximize programming efficiency
Check resulting output
Ensure consistency across items
Plan and document timelines
Forecast resource needs
Suggest work may be out of scope
Identify risks to project delivery
Proactively avoid risks
Propose solutions to mitigate risks
Assist with protocol development
Assist with sample size calculation
Assist with protocol review
Assist with case report form (CRF) review
Perform quality control (QC) review of protocol
Review CSR or statistical report
Serve as primary point of contact
Consult on operational topics
Handle the database lock
Handle the unblinding process
Participate on biostatistics randomization team
Draft randomization specifications
Perform quality control (QC) review of randomization schedules
Serve as unblinded lead statistician
How You'll Work.
Team & Collaboration
works closely with the Project Team Lead; Build and maintain effective customer relationships; Actively participates in internal project team meetings; Ability to provide and accept direction of lead team members; Ability to establish and maintain effective working relationships with coworkers, managers and clients
Communication Scope
Excellent written and oral communication skills; grammatical/technical writing skills; Demonstrates and promotes efficient communication
Process & Methodology
Perform data management lead role on single studies, deliver on time, with high quality and within budget, Plans and documents timelines, forecasts resource needs, suggests work may be out of scope, Identifies risks to project delivery, proactively avoid as well as proposes solutions to mitigate risks, anticipate risks to minimize need for study level escalations
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