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Biostatistician Ii - Non-Clinical

5-8 years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Remote 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 II - Non-clinical

Job ID: R0000029701
Category: Biostatistics
Location: India, Remote
Date Posted: 01/24/2025

Role Overview:

The Biostatistician II - Non-clinical position involves contributing to statistical strategies and providing statistical expertise for bioanalytical and pharmacokinetic studies. This position will focus on supporting non-clinical bioanalytical assay development, GLP, and non-GLP drug safety studies.

Key Responsibilities:

  • Study Design and Development:
    • Contribute to the design of studies, including bioanalytical assays, pharmacokinetic studies, and drug safety studies.
    • Develop study protocols, statistical analysis plans (SAP), trial designs, and case report forms (CRFs).
  • Statistical Leadership:
    • Lead the production and quality control of randomization, statistical analysis plans, statistical reports, and statistical sections of integrated clinical reports.
    • Ensure the quality and integrity of statistical outputs for nonclinical and clinical studies.
  • Sample Size and Randomization:
    • Perform sample size calculations for studies.
    • Generate randomization lists for trials and studies.
    • Write statistical methodology sections for inclusion in study protocols.

Qualifications:

  • Education:
    • PhD or Master’s degree in Statistics or a related discipline.
  • Experience:
    • 5-8 years of relevant experience in bioanalytical and pharmacokinetic studies.
  • Skills:
    • Expertise in statistical strategies for bioanalytical assay development.
    • Familiarity with GLP and non-GLP drug safety studies.
    • Experience in protocol development, study design, and statistical reporting.
    • Proficient in performing sample-size calculations, generating randomization lists, and writing statistical methodology sections for study protocols.

Additional Information:

  • Remote Role: This is a remote position, providing flexibility in work location.

Let me know if you'd like to adjust or expand on any section!