岗位职责：

•  Perform internal programmatic development and validation, or review of CRO-delivered SDTM, analysis datasets, and TLFs produced by statistical vendors. Ensure deliverable quality for studies and integrated analyses and help expedite the preparation of regulatory submissions. Review CRF annotations and SDTM datasets, identify data inconsistencies, and support ongoing data surveillance. Review SDTM and analysis dataset specifications to ensure correct interpretation of the SAP. Develop independent programs to create/validate or review SDTM, analysis datasets, and TLFs, ensuring compliance with CDISC standards and submission requirements. Develop or review the submission data package and ensure its quality and integrity.

•  Provide statistical programming support for pivotal studies and Integrated Summary of Safety and Efficacy (ISS/ISE) for oncology submission compounds, helping to expedite oncology regulatory submissions.

•  Provide programming support for submissions, including rapid-turnaround exploratory analyses and responses to regulatory agencies. Create analysis datasets (including specifications) and TLFs for submissions, respond to agency questions, perform ad hoc analyses requested by the clinical team, and support potential Oncology Drug Advisory Committee (ODAC) activities.

•  Support the development of company- and/or compound-specific programming standards for datasets and TLFs to improve efficiency and quality.

•  Develop and maintain programming macros to support programming deliverables and data surveillance effectively.

资历要求：

• BS or MS or equivalent degree in statistics/biostatistics, mathematics, computer science or related discipline.
• Minimum 2 years of experience.
• Excellent language skills in both English and Chinese (fluent in verbal and written).
• Proficiency in SAS programming skills, other programming skills (e.g., R or Python) is preferrable.
• Working knowledge of CDISC SDTM and ADaM.
• Understanding of statistical concepts in support of analyses and reporting of clinical trials
• Oncology knowledge of drug development and knowledge of regulatory authority’s requirements preferred.
• Accountable, dedicated, persistent, and flexible.
• Proficient SAS programming skills, and with good command of computer