Senior Biostatistician I / II - India - Office or Home
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking a Senior Biostatistician to join our diverse and dynamic team. As a Senior Biostatistician at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of creative treatments and therapies.
What you will be doing:
- Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies
- Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies
- Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports
- Program using SAS and/or R for inferential statistics
- Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients
- Participate in bid defense meetings and make presentations at marketing meetings with prospective clients
- Mentor or provide support to junior statisticians
- Lead or partake in initiatives to improve internal processes or create new guidance
Your profile:
- Master's degree OR Ph.D. in Biostatistics, Statistics, or a related field
- 6+ years of biostatistical experience in either a CRO, pharmaceutical, or biotech company
- Experience leading Phase II-III studies, including client facing responsibilities, timeline management, and resource oversight
- Experience working in a clinical research organization preferred
- Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications)
- Adv