Biostatistician 1
Job Details
Full Job Description
Job Overview
With appropriate support and guidance:
prepare analysis plans and write detailed specifications for analysis
files, tables, listings and figures, interpret analyses and write
statistical sections of study reports. Develop and maintain programs
to meet internal and external clients’ needs. Provide training,
guidance and mentorship to lower level and new staff.
Essential
Functions
• Production of High-Quality Deliverables: Completes
assigned tasks with focus on checking own work for 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: Demonstrates awareness of other
functions and their processes with respect to Biostatistics role in
the project and acts accordingly, including management of data quality
issues and resolution. Provide best in class solutions to
Biostatistics and Programming challenges.
• Datasets: With
appropriate support and guidance, programs datasets to industry
standards, maximizes programming efficiency with use of tools where
applicable. Handles analysis set derivations and assignment, under
supervision as needed.
• Tables, Listings and Figures (TLFs):
Programs TLFs and maximizes programming efficiency with use of tools,
where applicable. Checks resulting output for format and content, and
questions specification as needed. Ensures consistency across items
produced.
• Timelines: Accountable for delivering own work within
agreed timeframe and for identifying in a timely manner if a task
takes longer than expected to complete. Provides regular and timely
progress updates, shows awareness of how own progress impacts the
wider team. Under supervision, plans and documents timelines,
discusses forecast resource needs.
• Scope: Has a basic
understanding of 'scope of work' and budget assumptions. If new work
or re-work appears to be Out of Scope, raises with Project Team
Lead(s) in a timely manner.
• Risk Management: Identifies risks
to project delivery and/or quality to Project Team Leads and line
manager, makes suggestions to mitigate risks.
• Knowledge Sharing:
May mentor junior staff, provides knowledge sharing through
presentation/ discussion at team/ department meetings. Actively
participates in project team meetings. May help train 'new to IQVIA'
staff regarding operational items.
• Under Supervision
•
Leadership: Under close supervision, may take the role of Statistical
Team Lead for a single study or parts of a study. Through this, works
closely with the Project 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
SOP compliance. 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 CRF and
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: May author or perform review of SAP
and shells, where applicable.
• Specifications: Writes and
maintains specifications for assigned datasets and TLFs, where
applicable.
• Technology: Awareness and utilization of technology
offerings (Biostatistical Tools) rolled out by the Global business
unit. May be a contributor to development of technology
offerings.
• Other CDISC requirements: Perform quality control
(QC) review of define.xmls and/or SDTM and/or ADaM reviewers guide
(SDRG, ADRG).
• Risk Management: Consults team lead or manager in
identifying possible risks to minimize need for study level
escalations.
• Other Responsibilities: May serve as primary point
of contact for client. May consult on operational topics with clients.
May review or draft clinical study report (CSR) and/or statistical
report. May assist and contribute to request for proposal and bid
defenses, where deemed appropriate.
Qualifications
•
Bachelor's Degree Biostatistics or related field and 1-year relevant
experience Req
• Biostatistics or related field and 1 year
relevant experience
• Typically requires 1+ years of prior
relevant experience, or Equivalent combination of education, training
and experience.
• Requires knowledge of principles, theories, and
concepts of a job area, typically obtained through advanced
education.
• Strong planning and organizational skills.
• Very
good communication and interpersonal skills.
• Ability to handle
conflicting priorities and effectively manage multiple tasks and
projects.
• Ability to establish and maintain effective working
relationships with coworkers, managers and clients.
• Awareness of
relevant Data Standards (such as CDISC/ADaM/SDTM).
• Aptitude for
mathematical calculations and problem solving.
• Strong software
and computer skills, including Microsoft Office applications.
•
Extensive knowledge of Microsoft Excel.
• Results and
detail-oriented approach to work delivery and output.
• Excellent
customer service skills.
• Working knowledge of Microsoft server,
workstation and networking technologies.
• Knowledge of the
clinical drug development process.
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
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.
The potential base pay range for this role, when annualized, is $73,700.00 - $110,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Biostatistician 1
5PY US Quintiles
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