Senior Biostatistician
ROLE OVERVIEW
Joining IQVIA as a Senior Biostatistician in Bangalore places you at the analytical core of one of the world's largest clinical research organisations, where statistical rigour directly shapes regulatory submissions for global sponsors. In this role you own the statistical strategy for complex trials and integrated eSubmissions, translating raw clinical data into defensible evidence that regulators and payers can trust. IQVIA's Bengaluru hub supports dozens of Phase I-IV programmes across oncology, immunology, cardiology and rare disease, so the position offers exceptional therapeutic breadth. Because you lead study teams, negotiate timelines, mentor offshore statisticians and interface directly with clients, the role is a genuine springboard from hands-on programming into scientific leadership. It suits a seasoned biostatistician who wants scale, cross-functional exposure and a measurable impact on patients worldwide.
ROLE DEFINITION & RESPONSIBILITIES
- •Lead biostatistical activities on complex studies and integrated summaries, authoring statistical analysis plans and protocol statistical sections.
- •Write and maintain programming specifications for analysis datasets, ensuring CDISC/ADaM compliance and correct analysis-set derivations.
- •Review and QC tables, listings and figures; program complex main or validation outputs using SAS and Bios tools.
- •Manage database lock and unblinding processes, draft randomisation specifications and oversee unblinded statisticians.
- •Perform sample-size calculations and senior biostatistician review (SBR) for high-complexity trials.
- •Serve as primary client contact, negotiating scope, timelines and budgets, and presenting at bid defences.
- •Mentor and train statisticians across sites, sharing subject-matter expertise and supporting conference contributions.
- •Identify delivery and quality risks, drive mitigation, and own cost control and revenue recognition for assigned studies.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree in Biostatistics, Statistics or a related quantitative discipline; a Bachelor's degree with equivalent experience is considered.
- 5-7 years of hands-on biostatistics experience within a CRO, pharmaceutical or healthcare analytics environment.
- Proven lead-statistician experience across Phase I-IV clinical trials and integrated submission packages.
- Advanced working knowledge of SAS programming, plus familiarity with nQuery or similar statistical software.
- In-depth knowledge of ICH-GCP, CDISC and ADaM data standards.
- Excellent technical writing and client-facing communication skills.
- Demonstrated ability to lead and coordinate small statistical teams.
PREFERRED QUALIFICATIONS
- •nQuery / East
- •Oncology or Rare Disease Therapeutic Experience
- •R or Python for Statistical Computing
- •Bid Defence & Proposal Support
- •FSP Model Experience
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
IQVIA is a leading global provider of advanced analytics, technology solutions, and contract research services (CRO) to the life sciences industry. The company helps pharmaceutical, biotech, and medical device clients accelerate the development and commercialization of new medical treatments through its extensive data, technology, and human expertise. Their offerings span from clinical trial design and execution to real-world evidence and commercial effectiveness.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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