Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our Clinical Research team as a Principal Scientist in Biostatistics where youll contribute to advancing life-changing therapies through statistical excellence. As part of our Functional Service Provider (FSP) division youll work closely with clients while utilizing the benefits and resources of an established leader in clinical research. Youll be responsible for implementing diverse statistical tasks throughout the full clinical trial process from study design and protocol writing to final analysis and reporting. This position offers the opportunity to impact health outcomes while working with advanced clinical development programs.
REQUIREMENTS:
Ph. D or MS Biostatistics Degree plus minimum 10 years of experience in clinical research with emphasis on Phase I-III trials with compound Lead level experience
Preferred Fields of Study: Statistics Biostatistics or related quantitative field
Expert-level proficiency in SAS programming and statistical methodology
Strong knowledge of ICH-GCP guidelines and clinical trial regulations
Demonstrated experience in statistical analysis plan development and review
Ability to manage multiple clinical trials simultaneously
Advanced knowledge of CDISC standards and their implementation
Experience with statistical software packages such as R EAST or WinBUGS
Strong analytical and problem-solving skills
Excellence in written and verbal communication
Ability to interact effectively with regulatory authorities (FDA EMA)
Experience in CRO environment and vendor management preferred
Knowledge of auto-immune and/or oncology therapeutic areas beneficial
Demonstrated ability to work collaboratively in teams
Ability to meet deadlines and manage competing priorities
Strong attention to detail and quality focus
Required Experience:
Staff IC
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more