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Bio-Statistician I

0-2 years
Not Disclosed
10 March 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Bio-Statistician I
Company: Clinztech
Employment Type: Full-time
Schedule: [Day/Night Shift]

Job Responsibilities:

  • Perform statistical analysis on clinical trial data to support research and regulatory submissions.
  • Develop and implement statistical models for clinical studies.
  • Collaborate with clinical researchers, SAS programmers, and data managers to ensure high-quality data analysis.
  • Generate statistical reports, tables, and figures in compliance with regulatory guidelines.
  • Ensure adherence to CDISC (SDTM, ADaM), FDA, and ICH-GCP guidelines.
  • Conduct power/sample size calculations for study design optimization.
  • Provide statistical insights and recommendations for study protocols.
  • Assist in writing statistical analysis plans (SAPs) and clinical study reports (CSRs).

Requirements:

  • Education: Bachelor's/Master’s in Biostatistics, Statistics, Mathematics, or a related field.
  • Experience: 0-2 years of experience in biostatistics and clinical trial data analysis.
  • Skills:
    • Proficiency in SAS, R, or other statistical programming languages.
    • Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
    • Familiarity with CDISC standards (SDTM, ADaM) and clinical data management.
    • Excellent problem-solving, analytical, and communication skills.

Preferred Qualifications:

  • Experience with machine learning and predictive modeling in healthcare.
  • Knowledge of Bayesian statistics and advanced modeling techniques.
  • Certification in SAS (Base SAS, Advanced SAS) or Biostatistics is a plus.

Why Join Clinztech?

  • Opportunity to work on cutting-edge clinical research and statistical modeling.
  • Competitive salary and career growth opportunities.
  • Collaborative and innovative work environment.