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    Principal Biostatistician, Oncology Fsp (Remote)

    Fortrea
    8+ years
    Not Disclosed
    Remote, USA
    10 Aug. 8, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Principal Biostatistician, Oncology FSP (Remote) at Fortrea

    Company Overview:

    Fortrea is a leading global contract research organization (CRO) known for its scientific rigor and extensive clinical development expertise. We provide pharmaceutical, biotechnology, and medical device companies with a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees in more than 90 countries, Fortrea is dedicated to transforming drug and device development for our partners and patients worldwide.

    Position:

    Principal Biostatistician, Oncology FSP (Remote)
    Location: This is a remote position available to candidates across the U.S. and Canada. #LI-REMOTE

    Job Overview:

    At Fortrea, you’ll have the opportunity to make a significant impact on patient lives and advance your career in a high-energy, innovative environment. We are seeking a Principal Biostatistician to lead major global projects, analyze clinical study data, and provide strategic planning for multiple clinical studies. This role involves statistical oversight, project management, and mentoring, ensuring high-quality statistical analysis and data handling.

    Key Responsibilities:

    • Project Leadership: Lead complex studies, including NDA submissions and multi-protocol programs, coordinating activities across multiple locations and providing statistical oversight.
    • Project Management: Oversee project activities, including resource planning, timeline management, and milestone tracking.
    • DMC Support: Develop DMC Charters and participate in DMC Meetings as a Support Statistician, under the guidance of Statistical Consultants.
    • Statistical Analysis Plans: Develop and review complex Statistical Analysis Plans, ensuring comprehensive and accurate methodologies.
    • Statistical Analysis: Conduct and review complex statistical analyses, quality-checking analyses performed by other statisticians.
    • Protocol Development: Develop statistical sections of study protocols and review CRFs and other specifications.
    • Sample Size Calculations: Perform complex sample size calculations and develop randomization specifications and schedules.
    • Mentorship: Provide guidance and training to less experienced biostatisticians, ensuring accuracy and adherence to departmental policies.
    • Knowledge Sharing: Present at seminars and scientific meetings, and attend bid defense meetings for complex studies.
    • Subject Matter Expertise: Develop or review procedural documents, represent the department during audits, and contribute to new initiatives.

    Qualifications:

    • Education: Master’s degree or higher in Biostatistics or a related field.
    • Experience: Minimum of 8 years of experience in biostatistics, with at least 2 years in Oncology (Phase I, II, III studies, solid tumors, RECIST background). Experience with Survival Analysis and NDA submission studies preferred.
    • Technical Skills: Proficiency in statistical software packages (e.g., SAS®) and various statistical procedures, including non-parametric analysis, linear and non-linear models, categorical data, and survival analysis.
    • Communication: Proven ability to effectively communicate complex statistical concepts.
    • Clinical Knowledge: Strong understanding of the clinical trial process, including preparation of Statistical Analysis Plans and reporting.

    Salary & Benefits:

    • US Pay Range: $130,000 - $160,000 USD
    • Benefits: Comprehensive benefits package including Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid Time Off (PTO) or Flexible Time Off (FTO), and company bonus where applicable. Detailed information available upon request.

    Application Deadline: August 30, 2024

    Why Fortrea?

    Fortrea is dedicated to overcoming barriers in clinical trials and revolutionizing the development process to deliver life-changing therapies. Join our team and be part of a collaborative environment that fosters personal growth and makes a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer:

    Fortrea is committed to diversity and inclusion in the workforce. We do not tolerate harassment or discrimination of any kind and make employment decisions based on individual qualifications and business needs. We encourage all individuals to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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