📊 Advance Clinical Insights as Senior Biostatistician I/II
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Senior Biostatistician based in India. In this pivotal role, you'll lead statistical strategy for clinical trials, drive data interpretation, and contribute to groundbreaking therapies while enjoying office or home-based flexibility.
🎯 Your Impact: Key Responsibilities
Statistical Leadership & Strategy
- Serve as lead biostatistician for programs of studies, submissions, or complex individual studies
- Oversee statistical activities supporting client interactions and regulatory agency requirements
- Review and approve statistical methods sections of protocols and analysis plans
- Provide statistical input to clinical study reports and regulatory documents
Technical Excellence & Analysis
- Program using SAS and/or R for advanced inferential statistics and analyses
- Develop and implement statistical methodologies for clinical trial data
- Ensure statistical integrity and quality across all deliverables
- Support electronic submissions and regulatory documentation
Client Engagement & Business Development
- Participate in bid defense meetings and client presentations
- Prepare and approve research proposals and budgets for statistical consulting
- Build strong client relationships through technical expertise and collaboration
- Contribute to business development through statistical leadership
Team Development & Process Improvement
- Mentor and support junior statisticians in their professional growth
- Lead initiatives to improve internal processes and create new guidance
- Share statistical knowledge and best practices across the organization
- Foster a culture of continuous improvement and innovation
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Master's degree or Ph.D. in Biostatistics, Statistics, or related field
- 6+ years of biostatistical experience in CRO, pharmaceutical, or biotech company
- Experience leading Phase II-III studies with client-facing responsibilities
- Regulatory experience supporting submissions and handling regulatory requests
Technical Expertise
- Advanced programming skills in SAS and/or R
- Comprehensive knowledge of clinical trial methodologies and statistical approaches
- Experience with CDISC standards and regulatory requirements
- Strong understanding of statistical analysis plans and protocol development
Leadership Competencies
- Demonstrated leadership ability with effective team management skills
- Excellent written and oral communication capabilities
- Strong time management and prioritization skills
- Ability to plan, supervise, and monitor statistical processes for multiple studies
Preferred Qualifications
- Experience working in a clinical research organization
- Background in multiple therapeutic areas
- Publication or presentation experience
- Experience with adaptive trial designs
💫 Why Join ICON plc in India?
Professional Impact
- Lead statistical strategy for innovative clinical trials across multiple therapeutic areas
- Contribute to development of life-changing treatments and therapies
- Work with global teams on complex statistical challenges
- Influence clinical development through statistical expertise
Flexible Work Environment
- Choose between office-based or home-based work arrangements
- Access to cutting-edge statistical software and computing resources
- Modern collaboration tools for seamless remote work
- Support for professional development and continuous learning
Career Advancement
- Clear progression path to Principal and Leadership roles
- Opportunities for both technical and management career tracks
- Exposure to diverse study designs and therapeutic areas
- Support for advanced certifications and specialized training
Comprehensive India Benefits
- Competitive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Generous annual leave and flexible time-off policies
- Retirement planning and financial security benefits
Global Advantages
- Global Employee Assistance Programme with 24/7 support
- Life assurance coverage
- Professional development allowance
- Health and wellness programs
- International collaboration opportunities
✨ Ready to Lead Statistical Innovation?
If you're an experienced biostatistician with 6+ years in clinical research and strong leadership capabilities, we encourage you to apply. This role offers the perfect opportunity to advance your career while making meaningful contributions to clinical development and patient care.
Apply Now & Shape the Future of Clinical Statistics!
