Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated

On-site

Responsibilities

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

Your Profile Degree in a relevant field such as Mathematics, Life Sciences, Statistics, or Computer Science.
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 with regulatory submission deliverables, including Define.xml, ARM, and reviewers’ guides.
Business fluency in English, both spoken and written.

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.