Job Description
Responsibilities:
- Lead programming activities for oncology clinical trials across multiple studies.
- Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
- Provide SAS programming expertise to support complex data derivations and analyses.
Project and Study Management:
- Act as programming lead for assigned studies, managing timelines and deliverables.
- Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
- Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to programming standards.
Regulatory and Submission Support:
- Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
- Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
- Contribute to responses for regulatory queries and data requests.
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.