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Programming Lead

6+ years
Not Disclosed
10 Nov. 15, 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

Position: Lead Statistical Programmer
Company: Fortrea

About Fortrea:

As a global leader in contract research, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to drive innovation and excellence in clinical development. With a presence in over 90 countries and expertise across more than 20 therapeutic areas, Fortrea is committed to transforming drug and device development for patients worldwide.

Job Summary:

As a Lead Statistical Programmer, you will oversee programming activities for clinical studies, ensuring accuracy, timeliness, and quality across all project phases. You’ll collaborate with cross-functional teams, manage resources, and mentor junior programmers. Your expertise will support the generation of SDTM and ADaM datasets, TFLs, and regulatory-compliant documentation, contributing directly to the success of clinical trials.

Key Responsibilities:

  • Lead and oversee programming tasks for assigned studies, including resource estimation, budgeting, and meeting timelines.
  • Develop and validate SAS programs to create SDTM and ADaM datasets and TFLs.
  • Produce Define XML/PDFs, ARM, annotated CRFs, and Reviewers Guides for SDTMs and ADaMs.
  • Create specifications for SDTM and ADaM datasets.
  • Review SAPs and TFL shells to ensure alignment with programming requirements.
  • Mentor junior programmers on SDTM, ADaM, and TFL processes.
  • Present insights and share best practices at department meetings.
  • Support and respond to QA and client audits.

Qualifications:

  • Bachelor's degree in mathematics, statistics, computing, life sciences, or related field.
  • Minimum of 6+ years of SAS® programming experience within a CRO or pharmaceutical environment.

Why Fortrea?

At Fortrea, you’ll find a collaborative and growth-oriented work environment focused on scientific rigor and innovation. By joining our team, you will contribute to our mission of delivering life-changing therapies to patients in need, while furthering your professional development.

Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer committed to fostering an inclusive and diverse workplace. Employment decisions are based on business needs and individual qualifications, without regard to race, color, gender, national origin, sexual orientation, age, disability, or other protected status. We encourage all qualified applicants to apply.

For more information, visit www.fortrea.com