Statistical Scientist - Global BIOS
Descripción del trabajo
Join us on our exciting journey!
The Global Biostatistics (Data Sciences, Safety & Regulatory) team at IQVIA are experienced in submissions for all major regions; working together with key groups such as, Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing, to drive efficiency and accountability.
We have one of the largest Biostatistics departments within the industry of around 1,100+ staff, to which we engage the full range of industry-leading resources and expertise spanning all study phases and therapeutic areas.
Due to continued growth, we are seeking new brave minds to join our award winning and innovative department. You will have the opportunity to work globally and across a variety of therapeutic areas.
IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting.
As a Statistical Scientist, you will join one of the largest, award winning and innovative Biostatistics departments and will be given access to cutting-edge in-house technology, allowing you to work on global projects across a variety of therapeutic areas and thanks to our development opportunities and mentoring at all levels, you will be able to progress your long-term career in the direction you choose.
With visibility at a team/site/staff level, lead complex studies and submissions.
Develop protocols, review case report forms (CRFs), and develop analysis plans.
Provide input or write specifications for tables and analysis files.
Communicate with clients regarding study protocol or statistical analysis issues as they arise. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition.
Perform as lead statistician on complex studies and for integrated summaries or eSubmissions, where applicable.
Work 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.
Responsible for driving statistical discussions, actively participates in internal project team meetings, provides timely progress updates.
Run meetings, provides timeline updates, assess resource needs, and documents and follows up on actions.
Support colleagues and provide motivation
Writes and maintains programming specifications, with a focus on efficacy
Manages dataset derivations and assignment
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 and program complex Tables/Figures (Main or QC)
Plans, documents, and negotiates timelines forecasts resource needs, identifies out of scope work
Serves as primary point of contact for customer
Responsible for building and maintaining effective client relationships, providing direction, support, and oversight of statistical activities
Consults on operational topics with clients as well as on statistical/programming topics, regardless of complexity
Act as oversight on any study
Helps train staff regarding operational and technical items
Provides new topics and training materials at a department/site/ team/Global level
Act as subject matter expert (SME) to mentor senior staff, including offshore
Identifies risks to project delivery and/or quality, leads in a way that risks are avoided
Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions.
Lock and Unblinding Process: Leads the database lock and unblinding process.
Serves as unblinded lead statistician in addition to overseeing junior level Bios who are new to unblinding.
Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for complex and/or integrated reports)
Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)
Provide expert review of ADaM reviewers guide (ADRG)
Perform senior biostatistician review (SBR)
Produce or perform quality control review of sample size calculations for complex studies
Shares accountability (with resource managers) for the financial success of assigned studies.
Accountable for controlling costs and maximizing revenue recognition.
Responsible for sharing budget expectations with the team.
Responsible for negotiating out of scope work
Project leads collaborate on creation/revisions of Estimate at Completion (EAC) reporting
Able to review and comment on proposals/budgets at a study level
Contribute to request for proposals (RFP) as well as full-service proposals
Present at bid defense meetings and contribute to FSP bids
BSc or MSc degree in Biostatistics or related field, along with 7 + years’ experience within the life-science industry
Strong knowledge of complex statistical methods that apply to applicable clinical trials
Strong working knowledge of SAS and CDISC SDTM and ADaM
Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics
From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues.
What is in it for you?
Variety of therapeutic areas
Collaborative and supportive team environment
Access to cutting-edge in-house technology
Excellent career development and progression opportunities
Embrace your curiosity and grow your career in an exciting environment where development is a priority.
Think boldly and disrupt conventional thinking.
Enjoy what you do.
Whatever your career goals, we are here to ensure you get there!
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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