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Senior Biostatistician I

3-5 years
Not Disclosed
10 Dec. 6, 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

 

Senior Biostatistician I
Location: Remote
Company: ICON plc

Role Overview

ICON is seeking a Senior Biostatistician to join their team, providing expertise in statistical methodologies for clinical research. This role involves working with minimal supervision and applying a wide range of statistical techniques to support clinical trials and regulatory submissions.

Key Responsibilities

  • Study Design and Statistical Analysis:
    • Perform the role of Study Statistician, demonstrating strong statistical expertise in complex designs and methodologies (e.g., Bayesian, Estimands, Missing Data).
    • Contribute to the design, analysis, and interpretation of clinical trial data using applicable statistical approaches and software.
    • Author analysis plans and prepare statistical inputs for key documents and presentations.
    • Support the development of statistical strategy for studies and provide inputs to matrix team meetings when required.
  • Regulatory Knowledge and Quality Control:
    • Ensure deliverables are accurate, of high quality, and meet agreed timelines.
    • Demonstrate extensive knowledge of GxP, ICH, and regulatory processes.
    • Perform quality control (QC) of statistical work under supervision.
  • Collaboration and Vendor Management:
    • Participate in cross-functional team discussions and manage statistical processes across multiple clinical trials.
    • Experience in managing vendors is a plus.

Qualifications & Experience

  • Education:
    • Master's degree in statistics or biostatistics.
  • Experience:
    • Minimum of 5 years of biostatistical experience, including clinical trial involvement.
    • Expertise in multiple statistical areas, drug development processes, SAS procedures, and good programming practices.
    • Thorough knowledge of CDISC standards and ICH-GCP.
    • Experience with autoimmune or oncology clinical studies is a plus.

Skills & Knowledge

  • Strong expertise in statistical analysis for clinical trials.
  • Ability to plan, supervise, and implement statistical processes for multiple trials.
  • Knowledge of regulatory frameworks and industry standards.

Benefits

ICON offers a comprehensive benefits package, including:

  • Various annual leave entitlements
  • Health insurance options
  • Competitive retirement planning
  • Global Employee Assistance Programme
  • Life assurance and additional flexible benefits such as childcare vouchers, gym discounts, and health assessments.

Why ICON?
At ICON, we prioritize building a diverse and high-performing culture. We are committed to developing our people and providing opportunities for career growth. Our inclusive and supportive environment is designed to promote work-life balance and well-being.

Interested?
Even if you don’t meet all the requirements, we encourage you to apply. ICON is dedicated to finding the right fit for the team.

For more information, visit ICON Careers