岗位职责：

1. Perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies and integrated analysis, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data surveillance, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity.

2. Provide programming supports for submission and help submission team in quick turnaround in exploratory analysis and response to regulatory agencies. Responsivities include: create analysis dataset (including specifications) and TLFs to prepare submission, respond to agencies’ questions, perform ad-hoc analysis requested by clinical team, provide programming supports in potential Oncology Drug Advisory Committee (ODAC).

3. Support programming project lead to oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning as the backup of the programming project lead, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, maintain all required study programming documentation required for Trial Master File (TMF).

4. Support building up DS compound specific programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: support developing, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standards, develop/validate sample programs to generate standard ADaM dataset and TLFs, and develop and maintain programming macros to effectively support internal data review and data surveillance.

资历要求：

1. Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master's degree in bio/statistics preferred.

2. At least 2 years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming.

3. Advanced working knowledge of SAS programming language used in clinical trials programming.

Advanced working knowledge of CDISC ADaM, and extensive experiences of their implementation in clinical trials analysis.

Working knowledge of CDISC SDTM.

Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.

Having knowledge of drug development. Experiences of regulatory submission and supports are preferred.

Having solid background of applied statistics.

Solid knowledge of new advanced statistical methods using SAS and R is a plus.

Knowledge in database structures and set-up.