Sr Statistical Programmer

 Posted an hour ago
     
⭐ 5-10 years experience
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AI Summary

Develop, validate, and maintain ADaM datasets and TLFs in compliance with CDISC and regulatory standards. Collaborate with multidisciplinary teams to interpret analysis requirements and support regulatory submissions.
Sr. Statistical Programmer

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


We are seeking someone who can support both the development and ongoing maintenance of our standard ADaM metadata. You will have a solid understanding of CDISC ADaM is essential for this role. Typically, individuals with experience as a statistical programmer are well suited for this position. Additionally, experience in managing ADaM standards would be a valuable plus.

What You Will Do:

Your experience in statistical programming will be key in delivering high-quality outcomes and mentoring colleagues.

Key responsibilities include:

    • Develop, validate, and maintain ADaM datasets following CDISC standards and regulatory requirements (FDA, PMDA, EMA).
    • Program and generate Tables, Listings, and Figures (TLFs) to support clinical study reports (CSRs).
    • Collaborate with statisticians, data managers, and clinical teams to interpret analysis requirements.
    • Create and maintain ADaM specifications (define.xml, metadata, reviewers guides).
    • Perform quality control (QC) and validation of statistical programming outputs.
    • Ensure compliance with company SOPs, industry best practices, and regulatory guidelines.
    • Participate in study start-up activities, including annotation of CRFs and derivation specifications.
    • Troubleshoot programming issues and propose efficient solutions.
    • Support regulatory submissions and respond to health authority queries as needed.
    • Contribute to continuous process improvement and standardization efforts.

Your Profile:

You will have a strong foundation in statistical programming, with the experience to work independently and guide others.

Required qualifications and experience:

  • Bachelor's degree in statistics, computer science, mathematics, or a related discipline
  • Significant experience in statistical programming within the clinical research or pharmaceutical industry.
  • Strong proficiency in CDISC programming and a solid understanding of statistical concepts and methodologies.
  • Excellent analytical skills, attention to detail, and the ability to manage multiple projects simultaneously.
  • Strong communication and interpersonal skills, with the ability to work collaboratively within a multidisciplinary team.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

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