Senior Biostatistician I

Icon Plc

3-5 years

Not Disclosed

Remote

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

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Senior Biostatistician I

Job Description

Role Overview

Key Responsibilities

Qualifications & Experience

Skills & Knowledge

Benefits

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