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    Biostatistician

    Clinovo
    1-5 years
    Preffered by Company
    Remote
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Job Title: Biostatistician

    Position Overview:

    As a Biostatistician, you will leverage advanced statistical methods to support or lead Phase I-IV clinical studies in various areas including Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. Your role will involve providing statistical support for clinical studies, reviewing analysis datasets and efficacy tables, performing statistical analyses, interpreting results, and preparing clinical study reports, including integrated summaries for submissions.

    Key Responsibilities:

    • Provide statistical support and guidance for clinical studies.
    • Review and validate analysis datasets and efficacy tables (TLFs).
    • Perform statistical analyses and interpret results to inform study conclusions.
    • Prepare detailed clinical study reports and integrated summaries for regulatory submissions.
    • Communicate statistical methodologies and outcomes effectively to both technical and non-technical audiences.
    • Collaborate as a team player, demonstrating adaptability and flexibility to meet deadlines and manage changing priorities.

    Required Knowledge, Skills, and Abilities:

    • Excellent written and oral communication skills, including technical writing.
    • Exceptional attention to detail and accuracy.
    • In-depth understanding of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    • Familiarity with moderately complex statistical methods relevant to clinical trials.
    • Strong individual initiative and organizational skills.
    • Proficiency in SAS and other relevant statistical computing packages.
    • Commitment to quality and the ability to manage multiple tasks and projects effectively.
    • Capability to lead and coordinate small teams.
    • Problem-solving skills for moderately complex issues.
    • Knowledge of relevant data standards, such as CDISC/ADaM.

    Education and Experience Requirements:

    • PhD in Biostatistics or a related field with 1 year of relevant experience; or
    • Master’s degree in Biostatistics or a related field with 3 years of relevant experience; or
    • Bachelor’s degree in Biostatistics or a related field with 5 years of relevant experience; or
    • Equivalent combination of education, training, and experience.

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