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    Biostatistician

    Clinovo
    1-5 years
    Not Disclosed
    Remote
    10 July 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, 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 Overview:

    As a Biostatistician, you will utilize advanced statistical methods to support or lead one or more Phase I-IV clinical studies. These studies may focus on areas such as Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs.

    Key Responsibilities:

    • Statistical Support: Provide statistical support to clinical studies.
    • Data Review: Review analysis datasets and efficacy tables, listings, and figures (TLFs).
    • Statistical Analysis: Perform statistical analyses and interpret results.
    • Report Preparation: Prepare clinical study reports, including integrated summaries for submissions.
    • Communication: Present and explain methodology and the consequences of decisions in lay terms.
    • Team Collaboration: Serve as a team player, showing adaptability and flexibility when priorities change, and going the extra distance to achieve results and meet deadlines.

    Required Knowledge, Skills, and Abilities:

    • Communication Skills: Excellent written and oral communication skills, including grammatical/technical writing skills.
    • Attention to Detail: Excellent attention to detail and accuracy.
    • Regulatory Knowledge: In-depth knowledge of applicable clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
    • Statistical Methods: Familiarity with moderately complex statistical methods applicable to clinical trials.
    • Individual Initiative: Strong initiative and ability to work independently.
    • Organizational Skills: Strong organizing skills and ability to manage multiple tasks and projects effectively.
    • Technical Proficiency: Strong working knowledge of the SAS computing package and familiarity with other relevant statistical computing packages.
    • Quality Commitment: Strong commitment to quality.
    • Team Leadership: Ability to lead and coordinate small teams.
    • Problem Solving: Ability to solve moderately complex problems.
    • Data Standards: Working knowledge of relevant Data Standards (e.g., CDISC/ADaM).

    Minimum Required Education and Experience:

    • PhD in Biostatistics or related field with 1 year of relevant experience.
    • Master's Degree in Biostatistics or related field with 3 years of relevant experience.
    • Bachelor's Degree in Biostatistics or related field with 5 years of relevant experience.
    • Equivalent Combination: Equivalent combination of education, training, and experience may be considered.

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