Responsibilities
- Lead statistical programming efforts across multiple oncology clinical trials.
- Create, verify, and manage SDTM and ADaM datasets in compliance with CDISC standards.
- Supervise the development of Tables, Listings, and Figures for clinical study reporting and regulatory submissions.
- Deliver advanced SAS programming solutions for intricate data transformations and analytical needs.
- Conduct thorough reviews to confirm traceability, accuracy, and consistency of all programming outputs.
- Serve as primary programming lead for designated studies, overseeing timelines and deliverable completion.
- Collaborate with biostatistics, data management, medical writing, and regulatory teams.
- Manage programming coordination with contract research organizations and third-party vendors to ensure quality and alignment with client standards.
- Support integrated summary of safety and efficacy analyses.
- Produce final programming deliverables ready for regulatory submission, including define.xml files, annotated case report forms, and reviewer support documents.
- Ensure all programming activities comply with requirements from global regulatory agencies such as the FDA, EMA, and PMDA.
- Assist in preparing responses to regulatory authority data inquiries and requests.
Work Arrangement
Remote in US
Responsibilities
- 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.
- Provide SAS programming expertise to support complex data derivations and analyses.
- Review and ensure traceability, consistency, and quality of all programming deliverables.
- 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 client programming standards.
- Support integrated analyses including ISS/ISE.
- 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.
