Job Overview

Design study specific Common Data Models and eCRFs. Manage and harmonize raw data. Prepare quality checks and analysis plans and write detailed specifications for quality checking of raw and harmonized data, analysis files, tables, listings and figures. Provide training, guidance and mentorship to lower level and new staff.

Essential Functions

• Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on 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: Perform data management lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving data quality discussions, providing support and/or guidance for data enhancement activities. 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.
• Data Management: Assist in reviewing or advising data management staff on 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: Performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed.
• Datasets: Writes and maintains programming specifications. Programs assigned datasets to internal or industry standards. Handles dataset derivations and assignment.
• Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, 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: Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.
• Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed.
• Risk Management: Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations.
• Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
• Protocol: Performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods).
• Clinical Study Report (CSR): Reviews CSR or statistical report.
• Customer: On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.
• Lock and Unblinding Process: Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.