Statistical Scientist (Global Bios)

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.
Job Overview:
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.
Key Responsibilities:

• Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)
• Support colleagues and provide motivation
• Proposals:
• Act as subject matter expert (SME) to mentor senior staff, including offshore
• Tables, Listings and Figures (TLFs):
• Accountable for controlling costs and maximizing revenue recognition.
• Provides new topics and training materials at a department/site/ team/Global level
• Consults on operational topics with clients as well as on statistical/programming topics, regardless of complexity
• Responsible for driving statistical discussions, actively participates in internal project team meetings, provides timely progress updates.
• Serves as primary point of contact for customer
• Serves as unblinded lead statistician in addition to overseeing junior level Bios who are new to unblinding.
• Produce or perform quality control review of sample size calculations for complex studies
• Identifies risks to project delivery and/or quality, leads in a way that risks are avoided
• Perform as lead statistician on complex studies and for integrated summaries or eSubmissions, where applicable.
• Perform senior biostatistician review (SBR)
• Lock and Unblinding Process: Leads the database lock and unblinding process.
• Checks outputs for format and content and program complex Tables/Figures (Main or QC)
• Writes programming specifications for statistical analyses outputs
• Timelines:
• Responsible for building and maintaining effective client relationships, providing direction, support, and oversight of statistical activities
• Act as oversight on any study
• Manages dataset derivations and assignment
• Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions.
• Program analysis datasets, including complex domains and derivations
• Shares accountability (with resource managers) for the financial success of assigned studies.
• Present at bid defense meetings and contribute to FSP bids
• Responsible for sharing budget expectations with the team.
• Customer:
• Able to review and comment on proposals/budgets at a study level
• Writes and maintains programming specifications, with a focus on efficacy
• Run meetings, provides timeline updates, assess resource needs, and documents and follows up on actions.
• Contribute to request for proposals (RFP) as well as full-service proposals
• Responsible for negotiating out of scope work
• Financials:
• Datasets:
• Project leads collaborate on creation/revisions of Estimate at Completion (EAC) reporting
• 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)
• Helps train staff regarding operational and technical items
• 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.
• Handles analysis set derivations and assignment
• Risk Management:
• Provide expert review of ADaM reviewers guide (ADRG)
• Statistical Expertise:
• Plans, documents, and negotiates timelines forecasts resource needs, identifies out of scope work
• Knowledge Sharing:

Requirements:

• Strong working knowledge of SAS and CDISC SDTM and ADaM
• Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics
• 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

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?

• Work-Life Balance
• Access to cutting-edge in-house technology
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Excellent career development and progression opportunities
• Global exposure

JOIN US
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