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    Principal Cmc Statistician

    Amgen
    6+ years
    Not Disclosed
    Hyderabad
    10 Dec. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Here’s a refined version of the Principal CMC Statistician job description for Amgen:

    Position: Principal CMC Statistician

    Department: [Specify if provided]
    Location: [Specify if provided]

    About Amgen

    At Amgen, our mission is clear: to serve patients living with serious illnesses. Since 1980, we’ve pioneered advancements in biotechnology, tackling the world’s toughest diseases with innovative therapies. Operating across four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—our groundbreaking work touches millions of lives annually.

    As part of Amgen’s award-winning culture, you'll experience collaboration, innovation, and a commitment to improving life. Join our team to transform lives while building a fulfilling career.

    Role Overview

    In this critical role, the Principal CMC Statistician will contribute to Amgen’s product pipeline, applying advanced statistical tools to support the development and manufacturing of innovative therapies. The role spans process characterization, analytical methods, specifications, and device development while ensuring alignment with Amgen’s rigorous scientific and regulatory standards.

    As a key member of the team, you’ll drive continuous improvement initiatives, foster scientific innovation, and mentor others on statistical techniques and practices.

    Key Responsibilities

    Technical Leadership:

    • Develop, implement, and maintain statistical tools and techniques to support product life cycle activities.
    • Draft and update white papers, create standardized SAS/R code, and ensure alignment with Amgen’s SOPs and templates.

    Statistical Analysis and Collaboration:

    • Design and analyze experiments, document results, and ensure alignment with Amgen’s document control standards.
    • Provide statistical support for manufacturing processes, device development, analytical methods, and regulatory submissions.
    • Conduct acceptance sampling plans and establish evaluation criteria for Design Verification Testing (DVT).

    Regulatory and Compliance Support:

    • Assist with regulatory audits by responding to inquiries and performing supplementary analyses as required.
    • Stay informed about industry trends, guidance documents, and participate in external conferences.

    Mentorship and Training:

    • Provide training and mentorship on statistical methods and software tools for Amgen engineers and scientists.
    • Promote statistical best practices across the organization.

    Continuous Improvement:

    • Support initiatives to harmonize statistical processes, enhance efficiency, and drive scientific innovation.

    Qualifications

    Basic Qualifications:

    • Doctorate Degree in Applied/Industrial Statistics or Non-clinical Biostatistics with 2+ years of applied statistics experience, OR
    • Master’s Degree with 8-10 years of relevant experience, OR
    • Bachelor’s Degree with 10-14 years of relevant experience, OR
    • Diploma with 14-18 years of relevant experience.

    Preferred Qualifications:

    • Post-graduate degree with 6+ years in Biopharma manufacturing or control.
    • Proficiency in statistical methodologies, including:
      • Design of Experiments (DOE)
      • Statistical Process Control (SPC)
      • Process Capability Analysis
      • Measurement System Analysis
      • Regression Analysis
      • Simulation Techniques
    • Advanced programming skills in SAS, R, and JMP.

    Why Join Amgen?

    Professional Growth:

    • Ample opportunities for career advancement across our global organization.
    • A diverse, inclusive environment where innovation and ideas thrive.

    Comprehensive Benefits:

    • Competitive salary and a Total Rewards Plan encompassing health, finance, work-life balance, and career development.

    Impactful Work:

    • Directly contribute to transformative therapies that improve patient lives globally.

    Equal Opportunity Statement

    Amgen is an Equal Opportunity Employer, fostering diversity and inclusion. We ensure all individuals, including those with disabilities, receive reasonable accommodations during the hiring process and throughout their employment.

    Ready to Transform Lives?

    Apply now to make a difference while advancing your career in biotechnology.

    Visit careers.amgen.com

    Let me know if further adjustments are needed!

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