Senior Biostatistician

As a Biostatistician at IQVIA, you will play a crucial role in preparing analysis plans, writing detailed specifications for analysis files, tables, listings, and figures. You will interpret analyses and write statistical sections of study reports, providing training, guidance, and mentorship to lower-level and new staff.

• Production of High-Quality Deliverables: Complete and review complex assigned tasks with a focus on accuracy, conducting all appropriate validation requirements and checking programming logs for cleanliness and correct processing of data.
• Leadership: Perform statistical team lead role on single studies, working closely with the Project Team Lead and supervisor to deliver on time, with high quality, and within budget.
• Data Management: Assist in reviewing or advising data management staff on database design, validation checks, and critical data, handling data issue resolutions.
• Statistical Analysis Plan (SAP) and Shells: Author or perform quality control review of SAPs and shells, making best use of resources and expertise within the organization.
• Datasets: Write and maintain programming specifications, program assigned datasets to industry standards, and handle dataset derivations and assignment.
• Tables, Listings, and Figures (TLFs): Write programming specifications for statistical analyses outputs, program TLFs, and maximize programming efficiency with use of tools.
• Timelines: Plan and document timelines, forecast resource needs, and suggest work may be out of scope.
• Financials: Share accountability for the financial success of assigned studies, controlling costs, and maximizing revenue recognition.
• Knowledge Sharing: Help train staff regarding operational items, mentor junior staff, and support colleagues and provide motivation as needed.
• Risk Management: Identify risks to project delivery and/or quality and spend time to proactively avoid and propose solutions to mitigate risks.

• Bachelor's Degree in Biostatistics or related field and 1-3 years of relevant experience, or Master's Degree in Biostatistics or related field and 1-3 years of relevant experience, or Ph.D. in Biostatistics or related field.
• Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training, and experience.
• Excellent written and oral communication skills, including grammatical and 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, and 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, and ability to provide and accept direction of lead team members.
• Ability to solve moderately complex problems, establish and maintain effective working relationships with coworkers, managers, and clients, and working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).