IQVIA
Life sciences
Statistician
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Statistician at IQVIA. Skills: Statistical analysis, Clinical trials, Data interpretation. Develop statistical methods sections of protocols. Review case report forms (CRFs)”
What You'll Achieve.
Control costs; Maximize revenue recognition; Deliver on time; High quality delivery; Within budget
Industry & Context.
Data issue resolutions; Solve moderately complex problems; Risk management
What They're Looking For.
Must Have
Bachelor's Degree Biostatistics or related field and 3 - 5 years relevant experience, Master's Degree Biostatistics or related field and 3-5 years relevant experience, Ph. D. Biostatistics or related field and 1 year relevant experience, 3-5 years of prior relevant experience, Advanced knowledge of job area, Broad knowledge of other related job areas, Excellent written and oral communication skills, Excellent attention and accuracy with details, In-depth knowledge of applicable clinical research regulatory requirements, Familiarity with moderately complex statistical methods, Individual initiative, Organizing skills, Working knowledge of SAS computing package, Commitment to quality, Ability to effectively manage multiple tasks and projects, Ability to lead and co-ordinate small teams, Ability to solve moderately complex problems, Ability to establish and maintain effective working relationships, Working knowledge of relevant Data Standards
Nice to Have
PhD preferred, Familiarity with nQuery
What You'll Do.
Develop statistical methods sections of protocols
Review case report forms (CRFs)
Prepare analysis plans
Write specifications for analysis files
Communicate with clients regarding study protocol or statistical
Communicate with study team members regarding study execution
Write statistical sections of study reports
Maximize revenue recognition
guidance and mentorship to staff
Complete and review complex assigned tasks
Conduct validation requirements
Check programming logs
Input into Data Issues log
Follow issues to resolution
Perform statistical team lead role on single studies
Work closely with Project Team Lead and supervisor
Build and maintain effective customer relationships
Drive statistical discussions
Provide support or 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 or advising data management staff
Assist in reviewing or advising data management staff
Assist in reviewing or advising data management staff
Handle data issue resolutions
Handle lock and unblinding process
Perform quality control review of SAPs
Perform quality control review of shells
Make best use of resources and expertise
Perform QC review of complex SAPs
Write and 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
Plan and document timelines
Forecast resource needs
Suggest work may be out of scope
Share accountability for financial success of assigned studies
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 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 and take proactive approach to gain efficiencies
Assist with protocol development
Assist with sample size calculation
Assist with protocol review
Assist with case report form (CRF) review
Author statistical section of a protocol
Perform QC review of statistical section of a
Comment on proposal budgets
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
Reduce randomization schedules
Perform QC review of randomization schedules
Serve as unblinded lead statistician
Assist with cross functional collaboration
How You'll Work.
Team & Collaboration
Study team members; Project Team Lead; Customer relationships; Internal project team meetings; Data management staff; Biostatistics randomization team; Cross functional collaboration
Communication Scope
Oral communication; Written communication; Grammatical writing; Technical writing; Client communication; Study team communication; Customer communication; Progress updates; Bid defenses
Process & Methodology
Timelines, Resource needs, Scope of work, Budget expectations
Full Job Description
Job Overview Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. 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
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