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Cross-functional Leadership
Technical Leadership:
- Lead programming activities for oncology clinical trials across multiple studies.
- Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
- Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
Project & 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 and quality.
Regulatory & 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.
ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience, they employ more than 4,000 professionals across 20+ countries, fostering a culture of diversity and continuous training.