Senior Biostatistician w/m/d
- Experience Level
- Experienced (non-manager)
IQVIA is looking to appoint Senior Biostatistician to develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition. Provide training, guidance and mentorship to lower level and new staff.
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.
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.
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).
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.
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.
Serves as point of contact for customer for individual studies and responsible for building and maintaining effective client relationships. Consults on operational/statistical topics with clients.
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.
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.
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.
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. Handles most study level escalations that do not impact the account relationship and escalates for support to business segment owners/client owners/managers.
Able to review and comment on proposals/budgets at a study level. Contributes to request for proposals (RFP). Presents at bid defenses.
As defined on ad-hoc basis by managers. May assist with cross functional collaboration.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learnin
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.