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Principal Statistical Programmer

0-2 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Principal Statistical Programmer – Available in 3 Locations

Category: Clinical
Job ID: 2444693

About Fortrea:

Fortrea is a leading global contract research organization (CRO) dedicated to advancing clinical development with scientific rigor. Operating in around 100 countries, we provide pharmaceutical, biotechnology, and medical device companies with innovative solutions across more than 20 therapeutic areas. Our goal is to transform drug and device development for partners and patients around the world.

Role Overview:

As a Principal Statistical Programmer, you will take on a leadership role in statistical programming, overseeing and executing programming activities for clinical studies. This includes resource management, quality maximization, and collaboration with cross-functional teams to ensure project success.

Key Responsibilities:

  • Lead statistical programming activities, ensuring project delivery within scope, budget, and timelines.
  • Develop and maintain SAS programs to generate SDTM and ADaM datasets, TFLs, and perform quality control for SDTMs, ADaMs, and TFLs.
  • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTM and ADaM datasets.
  • Develop and lead the creation of complex specifications for SDTMs and ADaM datasets, contributing to Fortrea and client standards.
  • Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective and provide recommendations.
  • Mentor junior programmers in SDTM, ADaM, and TFL processes to ensure adherence to departmental practices.
  • Share knowledge through departmental presentations and discussions.
  • Respond to QA and client audits and assist in qualification audits.
  • Contribute to proposal activities and participate in bid defense meetings to secure new business opportunities.
  • Identify and propose efficiency improvements in statistical programming processes.
  • Perform additional duties as needed.

Why Join Fortrea?

We are seeking motivated and creative problem-solvers who are passionate about overcoming challenges in clinical trials. At Fortrea, you will thrive in a collaborative environment that fosters personal growth, allowing you to make a global impact in the healthcare industry.

Equal Opportunity Employer Statement:

Fortrea is dedicated to fostering diversity and inclusion and ensures employment decisions are based on qualifications and business needs. We do not tolerate discrimination based on race, gender, disability, or any other protected characteristic.

For more information, visit www.fortrea.com.