Senior Biostatistician – Hybrid Role in Thane
Location: Thane, India
Work Mode: Hybrid
Employment Type: Full-time
Salary/Compensation: Not specified in the job description
Job Summary
IQVIA is looking for an experienced Senior Biostatistician to lead statistical analysis for clinical trials and pharmaceutical studies. This role involves developing statistical sections of protocols, authoring SAPs, managing datasets, producing TLFs (tables, listings, figures), and providing mentorship to junior staff. The position requires advanced SAS programming skills, strong knowledge of CDISC standards, and expertise in GCP and ICH guidelines.
Key Responsibilities
Develop statistical methods sections for study protocols and review case report forms (CRFs).
Prepare analysis plans, programming specifications, and write statistical reports.
Perform statistical team lead role on studies, ensuring on-time and high-quality deliverables.
Review database design, validation checks, and assist data management teams.
Program and validate datasets, tables, listings, and figures using SAS and other statistical tools.
Provide mentoring, training, and guidance to junior staff and new team members.
Lead database lock and unblinding processes, randomization schedules, and quality control reviews.
Support proposal reviews, budgets, and participate in bid defenses as required.
Ensure compliance with GCP, ICH, and other regulatory requirements.
Collaborate with clients and internal teams on statistical and operational aspects of projects.
Required Skills & Qualifications
Bachelor’s, Master’s, or Ph.D. in Biostatistics or related field with 3–7 years of relevant experience.
Advanced expertise in SAS programming; familiarity with nQuery and other statistical packages.
Knowledge of CDISC/ADaM data standards and clinical trial data structures.
Strong understanding of statistical methods for clinical trials.
In-depth knowledge of GCP and ICH guidelines.
Excellent organizational, leadership, and problem-solving skills.
Ability to handle multiple projects and lead small teams effectively.
Excellent written and verbal communication skills.
Perks & Benefits
Hybrid work model offering flexibility and work-life balance.
Opportunity to work on global clinical trials and cutting-edge biostatistics projects.
Training and mentorship programs for professional growth.
Competitive work environment with career advancement opportunities.
Company Description
IQVIA is a global leader in clinical research, healthcare data analytics, and pharmaceutical intelligence. We partner with life sciences organizations worldwide to drive innovation, accelerate clinical development, and improve patient outcomes.
Work Mode: Hybrid (Thane, India).
Call-to-Action
Are you passionate about statistical analysis and clinical research? Apply now for the Senior Biostatistician role at IQVIA and shape the future of global healthcare solutions.
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