Senior or Principal Statistical Programmer

2 semanas atrás

São Paulo, Brasil Fortrea Tempo inteiro

**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.

Learn more about our EEO & Accommodations request here.

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