Senior Biostatistician
ROLE OVERVIEW
The Senior Biostatistician at IQVIA in Bengaluru is a strategic, client-facing role at the intersection of clinical trial design, regulatory-grade evidence, and advanced analytics. IQVIA supports pharmaceutical, biotechnology, and medical device sponsors across global programs, so this position directly influences how studies are powered, analyzed, and reported. The role owns statistical methods sections, analysis plans, datasets, and tables, listings, and figures (TLFs) while guiding junior staff and collaborating with data management, clinical, and programming teams. It is compelling for professionals who want to deepen expertise in CDISC, ICH-GCP, and modern trial methodology while gaining leadership exposure, budget accountability, and direct client interaction. It also offers a pathway into principal, team lead, or sponsor-side biostatistics roles in India’s rapidly expanding life-sciences market.
ROLE DEFINITION & RESPONSIBILITIES
- •Author or perform QC review of statistical methods sections, sample size calculations, protocols, and case report forms (CRFs) for complex clinical trials.
- •Develop statistical analysis plans (SAPs), table shells, and programming specifications, leveraging internal libraries and templates for efficiency.
- •Program, validate, and maintain analysis datasets and TLFs using SAS, ensuring alignment with CDISC/ADaM standards and protocol requirements.
- •Serve as statistical team lead on single studies, managing timelines, resource forecasts, budgets, EAC reporting, and scope-of-work changes.
- •Communicate with clients and cross-functional teams on statistical issues, data quality, database design, validation checks, and result interpretation.
- •Handle database lock and unblinding processes, randomization specifications, and quality control of randomization schedules as needed.
- •Draft statistical sections of clinical study reports (CSRs), support regulatory submissions, and participate in proposals, RFPs, and bid defenses.
- •Mentor and train junior biostatisticians, identify project risks, and propose mitigation strategies to protect delivery and quality.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master’s degree or PhD in Biostatistics, Statistics, or a closely related field; Bachelor’s degree with strong relevant experience may be considered.
- 3–5 years of clinical trial biostatistics experience; PhD holders typically require at least 1 year of relevant experience.
- Advanced working knowledge of SAS for statistical programming, data manipulation, and TLF generation.
- In-depth understanding of ICH-GCP, applicable clinical research regulations, and regulatory submission expectations.
- Familiarity with CDISC/ADaM data standards and moderately complex statistical methods used in clinical trials.
- Excellent written and oral communication, grammatical/technical writing, attention to detail, and accuracy.
- Proven ability to manage multiple projects, lead small teams, solve moderately complex problems, and build client relationships.
PREFERRED QUALIFICATIONS
- •R or Python for statistical computing
- •Oncology, immunology, or rare disease therapeutic experience
- •FDA/EMA submission support
- •Bayesian or adaptive trial methods
- •Mentoring and team leadership exposure
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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