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Biostatistician Ii/ Principal Biostatistician

5+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Biostatistician II/Principal Biostatistician at ICON plc

Location: Chennai, Trivandrum, India (Hybrid: Office/Remote)
Job Type: Full-time, Permanent
Job ID: JR127458


About ICON plc
ICON plc is a leading healthcare intelligence and clinical research organization (CRO). We're dedicated to shaping the future of clinical development with a focus on driving innovation and excellence. Join us in a dynamic, inclusive environment, and make an impact on patients' lives globally.


Role Overview

ICON is looking for an experienced Biostatistician II/Principal Biostatistician to join our team. You will play a key role in the analysis and reporting of clinical trial data, ensuring statistical rigor and supporting regulatory submissions. Your expertise will directly contribute to advancing healthcare through innovative clinical research.


What You Will Be Doing:

  • Statistical Analysis: Perform statistical analysis of clinical trial data and interpret results in compliance with regulatory standards (e.g., GCP, ICH).
  • Data Standards: Expertise in SDTM, ADaM, TLF, Graph, and CRT packages.
  • Programming: Use R and SAS to analyze data and generate reports. Hands-on experience with R programming and advanced SAS skills are required.
  • Collaboration: Work closely with clinical teams to develop and implement analysis plans and ensure high-quality deliverables.
  • Documentation: Prepare statistical analysis plans (SAP), analyze clinical trial data, and generate reports for regulatory submissions.
  • Regulatory Compliance: Ensure compliance with industry standards and regulatory requirements.

Your Profile:

  • Educational Qualification: Master’s or PhD degree in Statistics or related field.
  • Experience:
    • Minimum of 3 years for PhD holders, 5 years for Master’s degree holders in the pharmaceutical/CRO industry.
    • Hands-on experience with SDTM, ADaM, and other statistical analysis standards.
    • Proficient in SAS programming (ideally 5 years or more) and R programming.
  • Skills:
    • Knowledge of regulatory requirements and industry guidelines (e.g., ADaM, GCP, ICH).
    • Strong analytical and problem-solving skills.
    • Experience in pharmaceutical or contract research organization (CRO) settings.

What ICON Can Offer You:

  • Competitive Salary: ICON offers competitive salary packages along with annual performance bonuses.
  • Health & Well-being Benefits: Health insurance options for you and your family, and additional benefits like life assurance.
  • Retirement & Financial Planning: Competitive retirement plans to help secure your future.
  • Work-life Balance: A range of flexible benefits, including childcare vouchers, gym memberships, health assessments, and more.
  • Diversity & Inclusion: ICON fosters a diverse and inclusive culture, empowering employees to be their authentic selves at work.

Apply Today
If you’re passionate about clinical research and want to make a tangible impact, we encourage you to apply. Even if you don’t meet every requirement, apply – we may have other opportunities that suit your skills.

Equal Opportunity Employer
ICON is committed to creating an inclusive and accessible environment for all candidates, ensuring equal consideration for all applicants.