IQVIA
Life sciences
Biostatistician2
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Biostatistician 2 at IQVIA. Skills: Statistical analysis, Data management, Programming, Leadership. Prepare analysis plans. Write detailed specifications for analysis files, tables, listings”
What You'll Achieve.
Deliver on time; Deliver with high quality; Deliver within budget; Maximize programming efficiency; Control costs; Maximize revenue recognition
Industry & Context.
Solve moderately complex problems; Data issue resolutions; Risk management
What They're Looking For.
Must Have
Bachelor's Degree Biostatistics or related field and 1 - 3 years relevant experience, Master's Degree Biostatistics or related field and 1-3 years relevant experience, Ph. D. Biostatistics or related field, 1-3 years of prior relevant experience, Intermediate level knowledge of principles, theories, and concepts of a job area, In-depth knowledge of applicable clinical research regulatory requirements, Familiarity with moderately complex statistical methods, Working knowledge of SAS computing package, Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM)
Nice to Have
Ph.D. Biostatistics or related field
What You'll Do.
Prepare analysis plans
Write detailed specifications for analysis files
Write statistical sections of study reports
Provide mentorship to lower level and new staff
Complete and review more complex assigned tasks
Conduct all appropriate validation requirements
Check programming logs for cleanliness and correct processing
Input into Data Issues log
Follow issues to appropriate resolution
Perform statistical team lead role on single studies
Work closely with the Project Team Lead and
Build and maintain effective customer relationships
Drive statistical discussions
Provide support for statistical activities
Provide guidance for statistical activities
Participate in internal project team meetings
Provide timely progress updates
Provide input on estimate at completion (EAC) reporting
Assist in reviewing data management staff on database
Assist in advising data management staff on database
Assist in reviewing data management staff on validation
Assist in advising data management staff on validation
Assist in reviewing data management staff on critical
Assist in advising data management staff on critical
Handle data issue resolutions
Handle lock and unblinding process with appropriate supervision
Perform quality control review (QC) of SAPs
Perform quality control review (QC) of shells
Make best use of resources and expertise within
Write programming specifications
Maintain programming specifications
Program assigned datasets to industry standards
Handle dataset derivations
Handle dataset assignments
Write programming specifications for statistical analyses outputs
Maximize programming efficiency with use of tools
Check resulting output for format and content
Question specification as needed
Ensure consistency across items produced
Forecast resource needs
Suggest work may be out of scope
Share accountability for the financial success of assigned
Maximize revenue recognition
Share budget expectations with the team
Raise concerns to manager if new work or
Understand 'scope of work'
Be aware of contract and budget assumptions
Help train staff regarding operational items
Provide motivation as needed
Identify risks to project delivery and/or quality
Proactively avoid risks
Propose solutions to mitigate risks
Anticipate risks to minimize need for study level
Perform statistical team lead role on studies within
Prioritize work across protocols
Take proactive approach to gain efficiencies in work
Assist with protocol development
Assist with sample size calculation
Assist with protocol review
Assist with case report form (CRF) review
Author the statistical section of a protocol
Perform quality control (QC) review of the statistical
Comment on proposals budgets at a study level
Contribute to request for proposals (RFP)
Present at bid defenses
Review statistical report
Draft statistical report
Serve as primary point of contact for customer
Consult on operational topics with clients
Handle the database lock process
Handle the unblinding process
Participate on the biostatistics randomization team
Draft randomization specifications
Perform quality control (QC) review of randomization schedules
Serve as unblinded lead statistician
Assist with cross functional collaboration
How You'll Work.
Team & Collaboration
Work closely with Project Team Lead; Work closely with supervisor; Build and maintain customer relationships; Cross functional collaboration
Communication Scope
Written communication; Oral communication; Grammatical writing; Technical writing; Efficient communication
Process & Methodology
Plan timelines, Forecast resource needs, Control costs, Manage tasks
Full Job Description
Job Overview Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff. Essential Functions • Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (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. • Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. 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. • Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. • Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed. • Datasets: Writes and maintains programming specifications. Programs assigned datasets to industry standard
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