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Principal Biostatistician

Thermo Fisher Scientific
  • Wilmington, North Carolina
    28 days ago

    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

    Numbers & Facts

    LocationWilmington, North Carolina
    IndustryAll
    Company Size10,000 employees or more
    Websitehttps://corporate.thermofisher.com/en/home.html

    About Company

    Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

    All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

    If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

    Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

    Skills

    • Analysis Skillsunmatched
    • Biostatisticsunmatched
    • Cancerunmatched
    • Clinical Data Interchange Standards Consortium (CDISC)unmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Contract Research Organization (CRO)unmatched
    • Detail Orientedunmatched
    • Drug Developmentunmatched
    • FDA Requirementsunmatched
    • Food Safetyunmatched
    • GCP (Good Clinical Practices)unmatched
    • ICH Regulationsunmatched
    • Oncologyunmatched
    • Phase I Clinical Trialsunmatched
    • Phase III Clinical Trialsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Programming Methodologiesunmatched
    • Protocol Designunmatched
    • R Programming Languageunmatched
    • Statistical Analysis System (SAS)unmatched
    • Statistical Programming Languagesunmatched
    • Statisticsunmatched
    • Statistics Softwareunmatched
    • Team Playerunmatched
    • Time Managementunmatched
    • Vendor/Supplier Managementunmatched

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