Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated

Fortrea; Thatcham; Remote; GBP 50,000 - 70,000; Full time

Job summary

A global healthcare company is seeking a Senior or Principal Statistical Programmer to contribute to oncology clinical trials. In this role, you will utilize your SAS programming skills to develop and validate data analysis programs, ensuring compliance with quality standards. The ideal candidate has a degree in a relevant field and at least 4 years of experience in oncology trials. This position offers the flexibility to work 100% from home or from local offices.

Qualifications

• Minimum of 4 years' hands-on experience in oncology clinical trials is required.
• Proven experience with SAS programming and ability to debug complex programs.
• Business fluency in English, both spoken and written.

Responsibilities

• Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance.
• Develop and maintain SAS programs to create ADaM datasets and generate TFLs.
• Produce and validate regulatory submission deliverables.

Skills

SAS programming

CDISC standards (SDTM, ADaM)

regulatory submissions

programming accuracy and compliance

organizational skills

detail-oriented

Education

Degree in Mathematics, Life Sciences, Statistics, or Computer Science

Tools

Base SAS

SAS Macros

SAS/STAT

Job description

As a Senior or Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of complex global oncology clinical trials (Phases I-III) for some of the world's most renowned and innovative pharmaceutical companies.

In this role, you will contribute to the development of new and life-changing oncology therapies by developing and validating SAS programs for data analysis and reporting, supporting submissions, regulatory responses, publications, and post-hoc requests.

Your expertise will directly impact the advancement of oncology treatments and the lives of thousands of patients around the world.

You can be 100% home-based, or if you prefer, work from one of our local offices in your home country.

Your 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.

Your Profile

• 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.

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