Senior Biostatistician I / II - India - Office or Home
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent 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 straightforward 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