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16559-Biostatistician 2

IQVIA Holdings Inc.

Reading, United Kingdom

Job Overview


Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures. Interpret analyses and write statistical sections of study reports. 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.


• Performing 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. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.


• Statistical Analysis Plan (SAP) and Shells: Authors or 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 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.


• Other Clinical Data Interchange Standards Consortium (CDISC) requirements: Leadership: Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols.


• Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.


• Protocol: Authors or 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).


• Proposals: May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.


• Clinical Study Report (CSR): Reviews or drafts 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.


• Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.

Qualifications:


• Bachelor's or Master's Degree in Biostatistics or related field


• Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training and experience


• Intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience are required


• Excellent written and oral communication skills including grammatical/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 working knowledge of SAS computing package.

• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 2021-03-04

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