The major responsibilities of this position are to

1.Act as a core member in China Local Project Team (CLPT), partner with cross function in the strategic design and implementation of China development program.

2.Provide statistical expertise in protocol development including trial design, scenario simulation and sample size calculation based on relevant technical and scientific knowledge

3.Responsible and accountable for statistical deliverables for China local studies and assigned global studies by collaborating cross-functionally (e.g., data management, programming, medical writing) to ensure timelines and quality.

4.Work and collaborate with global statistical group to provide statistical expertise to support submission activities (such as IND/NDA), including but not limited to documents preparation, interaction with Health Authority, etc.

5.Take the oversighting role for outsourced STAT activities when needed

具体职责：

1.Act as a core member in China Local Project Team (CLPT), partner with cross function in the strategic design and implementation of China development program

-Play a key role in the CLPT, leading the strategic and operation planning of the statistical contributions to the China development plan of DS assets.

-Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making.

-Manage a good interaction with global key stakeholders, and represents DS China statistics to seek global counterpart’s support and alignment on DS China’s proposal when needed.

2.Provide statistical expertise in protocol development including trial design, scenario simulation and sample size calculation based on relevant technical and scientific knowledge

-Lead in the statistical design and review of clinical protocols, including preparation of statistical sections for China alone studies and assigned global studies

-Perform scenario simulations and sample size calculations for China subgroup of global study to support the best China development strategy

-Support assigned global activities

-Lead in the preparation and authoring of the SAP for China subgroup of global study, China alone studies and assigned global studies

-Generate statistical tables, listings and figures (TLFs) or perform QC validation of these TLFs to support CSR authoring, HA documents submission, publication, etc.

-Review reports that contain statistical inputs or data analysis results, ensure internal consistency of TFLs and accuracy of the report or publication text

-Understand the China regulation of statistics in drug development well and be responsible to prepare the statistical documents for submission

-Ensure the high quality of the statistical documents to be submitted to HA

-Provides responses to queries relating to study design, analysis and interpretation posed by HA

5.Take the oversighting role for outsourced statistical activities when needed

-Provide oversight to vendor to ensure the quality and speed of the statistical tasks. Actively oversee the project timeline and work closely with vendor to ensure all statistical related milestones are achieved

资历要求：

1. PhD, MS or equivalent degree in statistics/biostatistics or related discipline

More than 2 years for PhD or 4 years for MS working experience in pharmaceutical industry.

3. Excellent language skills in both English and Chinese (fluent in verbal and written).

4. Solid knowledge of statistical analysis methodologies and experimental design.

Good SAS and R programming skills.

Strong capability of work prioritization and deliver results with parallel multiple tasks.

Collaborative and open-minded, good communication skill

Accountable, dedicated, persistent, and flexible.

5.Good command of computer, good SAS and R programming skills