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Biostatistician

5+ years
Not Disclosed
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 Summary:

As a Senior 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. Your role will include providing statistical support, reviewing analysis datasets and efficacy TLFs, performing statistical analyses, interpreting results, and preparing clinical study reports, including integrated summaries for submissions.

Key Responsibilities:

  • Statistical Support:
    • Provide statistical support to clinical studies.
  • Data Review:
    • Review analysis datasets and efficacy TLFs.
  • Statistical Analysis:
    • Perform statistical analyses and interpret statistical results.
  • Report Preparation:
    • Prepare clinical study reports, including integrated summaries for submissions.
  • Communication:
    • Utilize strong communication skills to present and explain methodology and consequences of decisions in lay terms.
  • Team Collaboration:
    • Serve as a team player, demonstrating a willingness to go the extra distance to achieve results and meet deadlines. Adapt and remain flexible when priorities change.

Preferred Skills and Experience:

  • Communication:
    • Excellent written and oral communication skills, including grammatical/technical writing skills.
  • Statistical Methods:
    • Familiarity with moderately complex statistical methods applicable to Phase I-IV clinical trials.

Minimum Education:

  • Master’s degree in Statistics, Biostatistics, or a related health science field.

Minimum Experience / Training Required:

  • At least 5 years of statistical experience in the clinical trials or health research environment.

Note: This job description is intended to provide a high-level overview of the role and its requirements. It is not exhaustive and other duties may be assigned as necessary.