IQVIA
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 clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.