Biostatistician II / Senior Biostatistician / Lead Statistician based in Europe
IQVIA has approximately 55,000 employees in more than 100 countries, all committed to making the potential of Human Data Science a reality, and we are actively hiring.
We provide actionable solutions by tapping into the power of the IQVIA CORE™:
• Domain Expertise. Institutional knowledge and domain expertise across diseases, geographies and scientific methods
• Advanced Analytics. Faster, more precise decision-making generated by advanced analytics designed for healthcare
• Unparalleled Data. One of the world’s largest curated healthcare data sources with innovative privacy protections
• Transformative Technology. Leading technologies to provide real-time access to operations-critical information
As a Statistical Scientist you will 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.
As part of your responsibilities you will:
Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
Perform protocol development, sample size calculation, protocol and CRF review and also advise data management staff on database design, and critical data. May advise on validation checks.
Interpret analysis and craft statistical sections of integrated reports.
Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
Act as statistical team lead for single complex studies or groups of studies.
Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
Manage customer relationships and provide training and mentorship to junior staff members and newcomers.
All responsibilities are important job functions unless noted as nonessential (N).
Desired Skills and Experience
To meet our needs, you will:
Have excellent written and oral presentation skills including grammatical/technical writing skills and pay attention to the details
Have in-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Take strong individual initiative, show dedication to quality and present excellent organization skills
Show deep understanding of SAS computing package
Be familiar with other relevant statistical computing packages such as nQuery
Lead effectively multiple tasks and projects
You should also be able to:
Lead and co-ordinate small teams
Solve moderately complex problems
Establish and maintain effective working relationships with coworkers, managers and clients
Demonstrate deep knowledge of relevant Data Standards (such as CDISC/ADaM)
You should have PhD in biostatistics or related field and 1 year relevant experience; Master's degree in biostatistics or related field and 3 years relevant experience; Bachelor's degree in biostatistics or related field and 5 years relevant experience; or equivalent combination of education, training and experience
Extensive use of telephone, face-to-face communication requiring accurate perception of speech and of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Flexibility on travelling
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