Senior or Principal Statistical Programmer ONCOLOGY Sponsor dedicated
Share
Job Location:
Maidenhead - UK
Monthly Salary:
Not Disclosed
Posted on:
25-10-2025
Vacancies:
1 Vacancy
Job Summary
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 IIII) for some of the worlds 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 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 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.
Learn more about our EEO & Accommodations request here.
Required Experience:
Staff IC
Key Skills
- Tomcat
- Risk Management
- ICD Coding
- Solaris
- Solution Architecture
- PaaS
- Middleware
- Perl
- Weblogic
- Jboss
- NetSuite
- Oracle
