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    Biostatistics Associate Director

    Amgen
    4-8 years
    Not Disclosed
    Remote, USA
    10 Aug. 13, 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

    Position: Biostatistics Associate Director
    Type: Full-time, Remote
    Location: United States
    Job Requisition ID: R-183834
    Career Category: Clinical
    Posted on: 30+ Days Ago

    Job Description

    Company: Amgen
    Mission: To serve patients by researching, manufacturing, and delivering biotechnological products globally.

    Role Overview

    As a Biostatistics Associate Director, you will play a vital role in the oncology therapeutic area, ensuring that statistical aspects of clinical activities meet high standards. You will influence strategy development, participate in regulatory and safety submission activities, and collaborate with multidisciplinary project teams.

    Key Responsibilities

    • Provide statistical guidance in clinical development, reimbursement, and medical affairs.
    • Implement and manage standards in strategy, study design, and statistical analysis.
    • Plan and execute statistical contributions to protocols, Flash Memos, and Clinical Study Reports (CSRs).
    • Contribute to clinical publications and regulatory filing documents.
    • Lead and oversee work performed by study statisticians.
    • Perform statistical and exploratory analysis of studies/projects and develop conclusions.
    • Communicate resource and quality challenges affecting results or timelines.
    • Stay updated on regulatory guidelines in oncology drug development.
    • Contribute to process improvements and operational efficiencies.

    Qualifications

    Basic Qualifications:

    • Doctorate degree with 4 years of Biostatistics experience, or
    • Master’s degree with 6 years of Biostatistics experience, or
    • Bachelor’s degree with 8 years of Biostatistics experience.

    Preferred Qualifications:

    • Doctorate degree in Biostatistics or Statistics.
    • 6+ years of pharma/biotech statistical experience.
    • Experience in drug development across different stages (pre-clinical, clinical, post-marketing).
    • Prior experience in oncology drug development.
    • Statistical experience with regulatory and reimbursement submissions.
    • Proven leadership and team motivation skills.
    • Strong knowledge of theoretical and applied statistics and regulatory guidelines.
    • Excellent verbal, written, and organizational skills.
    • Experience working in a globally dispersed team environment with cross-cultural partners.

    What You Can Expect from Amgen

    • Total Rewards Plan: Health and welfare plans, retirement savings, and career development opportunities.
    • Comprehensive Benefits Package: Group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts.
    • Bonuses and Incentives: Discretionary annual bonus program or sales-based incentives for field sales representatives.
    • Stock-based Long-term Incentives.
    • Award-winning Time-off Plans: Including bi-annual company-wide shutdowns.
    • Flexible Work Models: Including remote work arrangements.

    Equal Opportunity Employment

    Amgen is an Equal Opportunity employer and considers all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Accommodations are available for individuals with disabilities during the job application or interview process.

    Apply Now:
    careers.amgen.com

    Note: This is a structured summary of the original job posting for the Biostatistics Associate Director position at Amgen.

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