Biostatistician

IQVIA

. Prepare analysis plans and write detailed specifications for analysis files, tables, listings, and figures .

Posted 10/19/2026full-timeShanghai • ChinaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Biostatistics with a strong focus on statistical analysis, programming, and compliance with Good Clinical Practice (GCP) and ICH guidelines. Capable of mentoring staff, managing project timelines, and ensuring high-quality deliverables in clinical trial settings.

Highest-signal resume keywords

BiostatisticsStatistical AnalysisSAS Computing PackageGood Clinical Practice (GCP)International Conference on Harmonization (ICH)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Analysis PlansProgramming SpecificationsDatabase DesignSample Size CalculationsStatistical ReportingData ValidationStatistical MethodsQC Statistical SectionsClinical Study ReportsCDISC/ADaM Standards

Soft Skills

Excellent Written CommunicationAttention to DetailOrganizing SkillsProblem-SolvingRelationship Management

Tools & Technologies

SASStatXact

Industry Keywords

Clinical TrialsProject ManagementStatistical DiscussionsData Issue ResolutionCross-Functional Collaboration

About the role

Key responsibilities & impact

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
Complete and review complex assigned tasks accurately and conduct validation according to SOPs
Check programming logs and contribute to data issue resolution
Perform statistical team lead responsibilities on assigned studies when applicable
Collaborate with Project Team Leads and supervisors to deliver work on time, with high quality, and within budget
Build and maintain customer relationships and lead statistical discussions
Participate in project meetings and provide progress updates
Advise data management staff on database design, validation checks, and critical data
Author or QC statistical analysis plans and shells
Write programming specifications and program datasets to industry standards
Write specifications and program tables, listings, and figures; check output format and content
Plan and document timelines and forecast resource needs
Monitor study financials, costs, revenue recognition, and budget expectations
Train and mentor staff and support colleagues
Identify project delivery and quality risks and propose mitigation solutions
Assist with protocol development, sample size calculations, protocol and CRF review
Author or QC statistical sections of protocols
Review proposals and budgets and contribute to RFPs and bid defenses
Review or draft clinical study reports and statistical reports
Serve as a customer point of contact and consult clients on operational topics
Handle database lock and unblinding processes
Participate in randomization activities and may serve as unblinded lead statistician
Assist with cross-functional collaboration and other ad hoc responsibilities

Requirements

What you’ll need

Bachelor's Degree Biostatistics or related field and 1 - 3 years relevant experience required, or Master's Degree Biostatistics or related field and 1-3 years relevant experience required, or Ph.D. Biostatistics or related field required
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
Excellent written and oral communication skills, including grammatical/technical writing skills
Excellent attention and accuracy with details
In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Familiarity with moderately complex statistical methods applicable to clinical trials
Strong individual initiative
Strong organizing skills
Strong working knowledge of SAS computing package
Familiarity with relevant statistical computing packages such as StatXact
Strong commitment to quality
Ability to effectively manage multiple tasks and projects
Ability to provide and accept direction of lead team members
Ability to solve moderately complex problems
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Working knowledge of relevant data standards such as CDISC/ADaM