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Principal Stats Programmer

0-2 years
Not Disclosed
10 Sept. 5, 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

As a leading global contract research organization (CRO) with a deep commitment to scientific excellence and extensive experience in clinical development, Fortrea offers a diverse range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 professionals operating in over 90 countries, Fortrea is at the forefront of advancing drug and device development for partners and patients worldwide.

Position: Lead Statistical Programmer

Key Responsibilities:

  • Leadership: Oversee and manage all programming activities for a study, including resource estimation, budget adherence, timeline management, quality optimization, and collaboration with other departments and clients.
  • Programming: Develop and maintain SAS programs for generating complete SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets, as well as Tables, Figures, and Listings (TFLs). Perform quality checks on SDTM, ADaM datasets, and TFLs.
  • Documentation: Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated Case Report Forms (aCRFs), and Reviewers Guides to support SDTM and ADaM datasets.
  • Specifications: Develop and/or lead the creation of complex specifications for SDTM and ADaM datasets and contribute to the development of Fortrea and client standards.
  • Review: Assess Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective, and advise on the development of complex TFL shells.
  • Mentorship: Guide less experienced programmers in SDTM, ADaM, and TFL processes, ensuring adherence to departmental practices and procedures.
  • Knowledge Sharing: Present and share expertise at departmental meetings.
  • Quality Assurance: Respond to QA and client audits, and support qualification audits.
  • Business Development: Contribute to proposal activities and participate in bid defense meetings to help secure new business.
  • Continuous Improvement: Continuously identify and propose ways to enhance the efficiency, quality, and productivity of statistical programming.

Fortrea is seeking motivated, innovative problem-solvers who share our passion for overcoming challenges in clinical trials. Our goal is to revolutionize the development process and ensure the rapid delivery of transformative therapies to patients. Join our exceptional team and thrive in a collaborative environment that supports personal growth and makes a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

Fortrea is committed to diversity and inclusion in the workplace. As an Equal Opportunity Employer (EOE/AA), we do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.