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    Senior Biostatistician, Oncology Fsp (Remote)

    Fortrea
    5+ years
    Not Disclosed
    Remote, USA
    10 Oct. 16, 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

    Senior Biostatistician, Oncology FSP (Remote)

    As a leading global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development experience, Fortrea provides comprehensive clinical development, patient access, and technology solutions across over 20 therapeutic areas. With operations in more than 90 countries, we are transforming drug and device development for partners and patients worldwide.

    Position Overview: We are seeking a Senior Biostatistician to lead major global projects in oncology. This permanent, remote role can be based anywhere in the U.S. The ideal candidate will analyze all aspects of clinical studies and provide strategic planning across multiple studies from various clients, including tracking project activities and managing timelines. The Senior Biostatistician will collaborate with other disciplines, offer technical solutions, supervise and mentor junior biostatisticians, and develop Statistical Analysis Plans (SAPs) encompassing statistical methodology and data handling procedures.

    Essential Job Duties:

    • Serve as Lead Biostatistician on medium-complexity studies, providing statistical oversight and participating in relevant project meetings.
    • Manage project activities, including resource planning and timeline management.
    • Prepare Statistical Analysis Plans (including mock TFL shells) for medium-complexity studies under the supervision of senior staff.
    • Conduct complex statistical analyses and quality-check analyses performed by other statisticians.
    • Review TFLs and perform overall statistical reviews prior to client delivery.
    • Review CRF and other study-specific specifications and plans.
    • Calculate sample sizes for simple studies under supervision.
    • Develop statistical sections of protocols for simple to medium-complexity studies with guidance from statistical consultants.
    • Provide statistical input and review Clinical Study Reports (CSRs) for medium-complexity studies.
    • Prepare and review randomization specifications and generate randomization schedules.
    • Mentor junior biostatisticians and lead training initiatives.
    • Present knowledge at team meetings and seminars, and participate in bid defense meetings for new business opportunities.
    • Represent the department during project-driven client audits.

    Qualifications:

    • Minimum Required: Bachelor’s degree in Biostatistics or a related field.
    • Recommended: Master’s degree or higher in Biostatistics or related field.
    • Experience: 5-8 years in biostatistics or a related field, with a minimum of 2 years in oncology across Phase I, II, and III studies (solid tumors and RECIST background).
    • Proficiency in SAS® for statistical analysis, including non-parametric analysis, linear/non-linear models, categorical data, and survival analysis.
    • Strong communication skills to effectively convey statistical concepts.
    • Knowledge of the clinical trial process, including experience in preparing SAPs and conducting analyses.

    Compensation and Benefits:

    • US Pay Range: $115,000 - $145,000 USD.
    • Comprehensive benefits for full-time employees working 20 or more hours per week, including medical, dental, vision, life insurance, 401(K), ESPP, and paid time off (PTO) or flexible time off (FTO).

    Application Deadline: November 15, 2024.

    Join Us: Fortrea actively seeks motivated problem-solvers and creative thinkers committed to revolutionizing clinical trials. Embrace a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer: Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications without discrimination based on race, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all to apply.

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