Instagram
youtube
Facebook

Principal Statistical Programmer

2+ years
Not Disclosed
10 March 19, 2025
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

Job Title: Lead Statistical Programmer

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]


About Fortrea:

Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development excellence. With over two decades of experience, we provide a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in around 100 countries, Fortrea is at the forefront of transforming drug and device development for global partners and patients.


Position Overview:

We are seeking a Lead Statistical Programmer to manage and oversee all programming activities on clinical studies. In this role, you will be responsible for the development and maintenance of SAS programs, including the creation of SDTM and ADaM datasets, TFLs, and other analysis outputs. You will also contribute to the development of complex specifications and standards for datasets, while mentoring less experienced programmers and leading programming activities within your team.


Key Responsibilities:

  • Lead programming activities on studies, including resource estimation, budget adherence, timeline management, and maximizing quality.
  • Develop and maintain SAS programs to create SDTM and ADaM datasets, TFLs, and perform QC of SDTM, ADaM datasets, and TFLs.
  • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTM and ADaM datasets.
  • Develop or lead the development of complex specifications for SDTMs and ADaM datasets, contributing to Fortrea and Client standards.
  • Review SAPs and TFL shells from a programming perspective and advise on complex TFL shell development.
  • Mentor junior programmers on SDTM, ADaM, and TFL processes, ensuring adherence to department practices.
  • Present knowledge and insights at department meetings to facilitate continuous learning.
  • Respond to QA and client audits, supporting qualification audits as required.
  • Contribute to proposal activities and participate in bid defenses to help win new business.
  • Continuously suggest improvements to enhance the efficiency, quality, and productivity of statistical programming.
  • Perform additional duties as needed or assigned.

Qualifications:

  • Experience: At least 5 years of experience in statistical programming, with a deep understanding of SDTM, ADaM, and TFLs.
  • Skills: Strong SAS programming skills, with the ability to develop and maintain complex statistical programming tasks.
  • Experience with Regulatory Compliance: Familiarity with global regulatory requirements for clinical data analysis and submission.
  • Leadership: Proven ability to lead teams, mentor junior programmers, and oversee programming activities from start to finish.
  • Collaboration: Ability to interact with multiple departments, clients, and stakeholders effectively.

Why Join Fortrea?

At Fortrea, we are driven by the passion to transform clinical trials and improve patient outcomes. Our collaborative, innovative environment encourages professional growth and offers the opportunity to make a global impact. Join us as we revolutionize drug development and bring life-changing therapies to patients worldwide.


Fortrea is an Equal Opportunity Employer:

As an Equal Opportunity Employer (EOE/AA), Fortrea is committed to creating a diverse and inclusive workforce. We do not tolerate discrimination or harassment and make employment decisions based on qualifications and business needs. We encourage candidates from all backgrounds to apply.

For more details on how we collect and store your personal data, please review our Privacy Statement.

If you require a reasonable accommodation due to a disability to complete your job application, pre-employment testing, job interview, or participate in the hiring process, please contact us at: taaccommodationsrequest@fortrea.com. This email address is for accommodation requests only and should not be used to check the status of your application.


Apply Now to Lead the Future of Clinical Trials at Fortrea!