- 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.
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