Job Description

With appropriate guidance and support, provide statistical support for the production and checking of statistical outputs and the development of analysis plans. Assist in trial design tasks and data management consultation.Essential Functions

• Production of High-Quality Deliverables: Completes assigned tasks with focus on reviewing own work for accuracy. Clearly follow instructions of project lead in the execution of project assignments. Seeks assistance when needed. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks programming logs for cleanliness and correct processing of data.
• Timelines and Communication: Attends internal project team meetings. Timely and accurate communication with internal/external stakeholders as deemed necessary. Provides timely progress updates to team lead. Supports colleagues as requested.
• Scope of Work: Exposure to 'scope of work', contract, pricing tool, and budget assumptions.
• Documentation: Create and review documentation as requested including but not limited to annotated CRFxe2x80x99s and specifications.
• Technology: Awareness and utilization of technology offerings (Biostatistical Tools) rolled out by the Global business unit.
• Under Supervision
• Datasets: Programs assigned datasets to industry standards.
• Tables, Listings and Figures (TLFs): Programs tables, listings and figures, checks output for format and content, and questions specification as needed. Ensures consistency across TLFs.
• Risk Management: Identifies risks to project delivery and/or quality to team lead.
• Customer: May serve as additional point of contact for client where appropriate for certain aspects. May consult on operational topics with clients where relevant and appropriate.
• Knowledge Sharing: Assist with training and development of new staff where applicable.
• Other Responsibilities: As defined on ad-hoc basis by managers. May review or draft clinical study report (CSR) and/or statistical report, perform data review and statistical analysis, assist with protocol development, protocol and review, and assist in advising data management staff on database design, validation checks and critical data. May author or perform review of statistical analysis plan (SAP) and shells, where applicable.

Qualifications

• Bachelor's Degree Biostatistics or related field and 1-year relevant experience Req
• Typically requires 1 year of prior relevant experience or equivalent combination of education, training and experience in lieu of degree.
• Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• Basic knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Familiarity with basic statistical methods that apply to Phase I-IV clinical trials.
• Strong individual initiative.
• Strong organizing skills.
• Strong aptitude for SAS computing package skills.
• Strong commitment to quality.
• Ability to effectively manage multiple tasks and projects.
• Ability to accept direction of lead team members.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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