Principal Biostatistician Thermo Fisher Scientific - 3.4 Wilmington, NC Job Details Full-time 1 hour ago Qualifications Statistics Quantitative applied research Statistics Biostatistics-based research SAS Pharmaceutical regulatory compliance Drug regulation SAS language ICH guidelines CDISC standards Clinical data analysis Achieving project delivery timelines FDA regulations Data analysis software Full Job Description Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll 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 world's 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 you'll contribute to advancing life-changing therapies through statistical excellence. As part of our Functional Service Provider (FSP) division, you'll work closely with clients while utilizing the benefits and resources of an established leader in clinical research. You'll 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

Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biostatistical experience in clinical research, with emphasis on Phase I-III trials

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