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Fortrea · 2 months ago

Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated

United States

Full-time

Remote

Senior Level, Lead/Staff

4+ years exp

Fortrea is a company dedicated to delivering complex global oncology clinical trials for renowned pharmaceutical companies. As a Senior or Principal Statistical Programmer, you will develop and validate SAS programs for data analysis and reporting, contributing to the advancement of new oncology therapies.

Clinical TrialsHealth Care

H1B Sponsor Likely

Responsibilities

Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance with study timelines and regulatory standards

Review SAPs and TFL shells from a programming perspective, providing technical input to optimize oncology analyses

Advise on the design and development of complex TFL shells and statistical outputs for oncology studies

Develop and/or lead the creation of specifications for SDTM and ADaM datasets

Develop and maintain SAS programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs); perform thorough quality control (QC) checks

Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions

Contribute to the preparation of regulatory submission packages and responses to regulatory and client audits

Identify, propose, and implement process improvements to enhance programming efficiency, quality, and standardization

Stay up to date on industry standards, global regulatory requirements, Fortrea SOPs, and CDISC developments relevant to oncology data

Qualification

SAS programmingOncology clinical trialsCDISC standardsRegulatory submission experienceAnalytical mindsetBusiness fluency in EnglishOrganizational skills

Required

Degree in a relevant field such as Mathematics, Life Sciences, Statistics, or Computer Science

Equivalent vocational training and/or significant professional experience in clinical statistical programming may be considered

Minimum of 4 years' hands-on experience in oncology clinical trials is required

Proven experience with SAS programming (Base SAS, SAS Macros, SAS/STAT) and ability to debug complex programs

Strong practical knowledge of CDISC standards (SDTM, ADaM) and experience generating safety and efficacy reporting outputs for Phase III oncology studies

Experience with regulatory submission deliverables, including Define.xml, ARM, and reviewers' guides

Strong organizational skills with an autonomous yet collaborative working style

A curious and analytical mindset, with a keen eye for detail and quality

Business fluency in English, both spoken and written

Company

Fortrea

Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.

Founded in 2023

Durham, North Carolina, USA

10001+ employees

https://www.fortrea.com

H1B Sponsorship

Fortrea has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (25)

2023 (6)