IQVIA is looking to appoint Biostatistician II to develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, 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.
- 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.
- Advise data management staff on database design, validation checks and critical data.
- Write statistical sections of integrated reports.
- Provide 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.
- Fulfill the Lead role for single complex studies or groups of studies.
- Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for studies.
- Perform the review of costings and attend bid defense meetings.
- Manage customer relationships.
- Provide training and guidance to lower level and new staff.
- Bachelor's Degree Biostatistics or related field and 2-3 years relevant experience Req Or
Master's Degree Biostatistics or related field and 2-3 years relevant experience Req Or
Ph.D. Biostatistics or related field Req
- Typically requires 2-3 years of prior relevant experience, or equivalent combination of education, training and experience.
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- 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.
- Strong individual initiative.
- Strong organizing skills.
- Strong working knowledge of SAS computing package.
- Familiarity with other relevant statistical computing packages such as StatXact.
- Strong commitment to quality.
- Ability to effectively manage multiple tasks and projects.
- Ability to provide and accept direction of lead team members.
- Ability to solve moderately complex problems.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.