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Senior Statistical Programmer Specialist

3+ 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

Senior Statistical Programmer Specialist

Location: Bangalore
Category: Clinical
Job ID: 2444697

About Fortrea:

Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and clinical development. With operations in approximately 100 countries, Fortrea provides a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, revolutionizing drug and device development for global partners and patients.

Role Overview:

As a Senior Statistical Programmer Specialist, you will be responsible for planning, executing, and overseeing programming activities within clinical studies. You will develop and maintain SAS programs to create SDTM and ADaM datasets, produce TFLs, and support regulatory submissions and client audits. In this role, you may also step into the position of Lead Statistical Programmer for CP studies with support from senior staff.

Key Responsibilities:

  • Oversee and execute programming activities on a study, including resource estimation, budget management, and meeting timelines.
  • Develop and maintain SAS programs to create SDTM and ADaM datasets, and perform QC of SDTM, ADaMs, and TFLs.
  • Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs, and Reviewers Guides to support SDTMs and ADaMs.
  • Assist in developing specifications for SDTM and ADaM datasets with support from senior programming staff.
  • Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective.
  • Respond to QA and client audits with guidance from senior programming staff.

Why Join Fortrea?

At Fortrea, you’ll be part of a passionate team of problem-solvers dedicated to overcoming barriers in clinical trials. Fortrea offers a collaborative environment that supports personal and professional growth, empowering you to make a global impact.

For more information, visit www.fortrea.com.