Sr Statistical Programmer

US-AnywhereRemote in Blue Bell, PA
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 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
  • Solid understanding of statistical concepts and methodologies
  • Excellent analytical skills and attention to detail

Responsibilities

  • Develop, validate, and maintain ADaM datasets following CDISC standards
  • Program and generate Tables, Listings, and Figures (TLFs) for clinical study reports
  • Collaborate with teams to interpret analysis requirements
  • Create and maintain ADaM specifications
  • Perform quality control (QC) of statistical programming outputs
  • Ensure compliance with SOPs and regulatory guidelines
  • Participate in study start-up activities and troubleshoot programming issues

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes
  • Learning and development opportunities
Full Job Description
Sr. Statistical Programmer

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 to read more about the benefits ICON offers.

About Pharmaceutical Research Associates, Inc

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Joining Pharmaceutical Research Associates, Inc presents an unparalleled opportunity to become part of a leading team in the pharmaceutical research industry. This company stands as a beacon of innovation, leadership, and professional growth.

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Pharmaceutical Research Associates, Inc is actively seeking skilled professionals eager to impact the world of pharmaceuticals and healthcare. With a variety of job opportunities available, candidates can find positions that match their skills and career ambitions perfectly.

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At Pharmaceutical Research Associates, Inc, the culture thrives on diversity, innovation, and a commitment to employee growth. The company offers comprehensive benefits designed to support the health, well-being, and financial security of each team member. From diversity training to leadership programs, employees are equipped with resources to thrive both professionally and personally.

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For those starting their career journey, Pharmaceutical Research Associates, Inc provides robust internship programs. These opportunities allow interns to work alongside experienced professionals, gaining invaluable industry insight and enhancing their resume through practical, hands-on experience.

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Career advancement is a cornerstone of employment at Pharmaceutical Research Associates, Inc. The company supports career growth through professional development programs, networking opportunities, and leadership training, ensuring that every team member has the tools to succeed.

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Pharmaceutical Research Associates, Inc is at the forefront of pharmaceutical innovation. The team is dedicated to pioneering research that leads to new discoveries and solutions in healthcare, offering employees a chance to contribute to meaningful projects that push industry boundaries.

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