Senior Biostatistician

IQVIA ,
Reading, Berkshire
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Overview

Job Description

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. Essential Functions Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks on time/early with a focus on accuracy. If in a team lead role, oversees team with same expectations. Conducts all appropriate validation requirements, according to SOPs, for each task undertaken. Checks data for cleanliness and correct processing. Inputs into Data Issues log and follows issues to appropriate resolution. Leadership: Perform statistical team lead role on complex studies and/or within a compound. Through this, works with the team to ensure high quality deliverables, delivers on time within budget, ensures compliance with SOPs, ensure consistency across teams and across protocols, manages/delegates data quality issue resolutions. As a lead of groups of studies within a compound, also prioritizes and leads proactively to gain efficiencies in work across protocols and deliver on time across multiple protocols. May also serve in statistical project oversight role for simple studies. Responsible for driving statistical discussions, actively participates in internal project team meetings, provides timely progress updates. In a lead role, runs meetings, provides timeline updates, assess resource needs, documents, and follows up on actions. Supports colleagues and provides motivation. Data Management: Reviews and advises data management staff on CRF and database design, validation checks and critical data. Leads data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision. Study Start up: Authors/QC statistical section of a protocol, with authors making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Produces/QCs sample size calculations. Covers complex studies Statistical Analysis Plan (SAP) and Shells: Authors and/or performs quality control review (QC) of SAPs and shells, makes best possible use of resources. Shares own expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). Datasets: Writes and maintains programming specifications, with a focus on efficacy. Manages dataset derivations and assignment. May program analysis datasets, including complex domains and derivations. Handles analysis set derivations and assignment. Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Checks outputs for format and content. Ensures consistency across items produced. May program complex Tables/Figures (Main or QC), using Bios tools where applicable. Clinical Study Report (CSR) : Reviews or drafts CSR or statistical report, under supervision as needed. Timelines : Plans, documents, and negotiates timelines, forecasts resource needs, identifies out of scope work. Lock and Unblinding Process: Leads 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. Customer : Serves aspoint of contact for customer for individual studies and responsible for building and maintaining effective client relationships. Consults on operational/statistical topics with clients. Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, CRF design, validation checks and critical data). Provide expert review of ADaM reviewers guide (ADRG). May perform senior biostatistician review (SBR), under supervision. Financials: Shares accountability (with therapeutic area leads and Director) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Also responsible for sharing budget expectations with the team. Responsible for negotiating out of scope work. Understands 'scope of work', contract, and budget assumptions. Project leads collaborate on creation/revisions of Estimate at Completion (EAC) reporting. Knowledge Sharing: Helps train staff regarding operational items. Provides training at a department/site/team/Global level. May be expected to act as subject matter expert (SME). Mentors senior staff, including offshore. Risk Management : Identifies risks to project delivery and/or quality,

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