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Biostatistician

1-3 years
Not Disclosed
10 Sept. 4, 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

Job Title: Biostatistician

Job Description:

As a Biostatistician, you will utilize advanced statistical methods to support or lead Phase I-IV clinical studies across various fields including Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. Key responsibilities include:

  • Providing statistical support for clinical studies
  • Reviewing analysis datasets and efficacy TLFs (Tables, Listings, Figures)
  • Performing and interpreting statistical analyses
  • Preparing clinical study reports and integrated summaries for submissions
  • Communicating methodology and implications clearly in lay terms
  • Collaborating as a team player, adapting to changing priorities, and meeting deadlines

Required Knowledge, Skills, and Abilities:

  • Excellent written and verbal communication skills, including technical writing
  • Strong attention to detail and accuracy
  • In-depth understanding of clinical research regulatory requirements (GCP, ICH)
  • Familiarity with complex statistical methods for clinical trials
  • Proficiency in SAS and other statistical computing packages
  • Strong organizational skills and ability to manage multiple projects
  • Ability to lead small teams and solve complex problems
  • Knowledge of data standards such as CDISC/ADaM

Minimum Required Education and Experience:

  • PhD in Biostatistics or a related field with 1 year of relevant experience
  • Master's degree in Biostatistics or a related field with 3 years of relevant experience
  • Bachelor's degree in Biostatistics or a related field with 5 years of relevant experience
  • Alternatively, equivalent education, training, and experience