Position Summary

(1)根据项目的需要，分析需求、编写统计程序、生成结果并确保结果正确、符合要求;

(2)开发SAS宏程序；

(3) 领导编程团队完成上述编程任务；

(4)管理客户、项目和团队；

(5) 协助维护SOPs。

(1) Per project needs, analyzes the requirements, writes SAS programs to generate results and makes sure the results are correct and meets the requirements;

(2) Develops SAS macros for projects and global library;

(3)lead team to complete the tasks as listed;

(4) Managesclients, projects, and staff;

(5)Support to maintains SOPs.

Key Responsibilities

映射/衍生列表数据集和分析数据集，生成统计表格、列表和图形TLFs。

验证列表数据集、分析数据集以及TLFs。

撰写列表数据集和分析数据集的映射说明文档

（使用SDTM变量）标注CRF

准备递交包

开发TLFs编程说明文档

按照项目需求开发SAS宏程序

生成随机盲表

管理项目资源、时间进度和资金预算

作为主要联系人和主办方沟通统计编程相关问题

和DM及统计师沟通编程相关问题

掌控项目进度并确保SOP、WI的合规

开发、维护中央SAS宏程序库

培训新员工

维护SOP、WI

不断优化工作流程

领导或支持更新更好的商业解决方案

协调SOP、WI的开发和实施

和高管团队保持高度互动，寻找新机遇并提出战略方案

领导团队

指导团队成员

招聘新成员

估算任务/时间

商业演示、展示

CDISC实施咨询

编程流程咨询

Maps/derives tabulation datasets and analysis datasets, generate TLFs.

Validates tabulation datasets, analysis datasets, and TLFs.

Develops mapping specs for tabulation datasets and analysis datasets

Annotates CRF (SDTM variables)

Prepares submission package

Develops TLFs programming specs

Develops macro per project needs

Generates Randomization schema

Manages project resources/timeline/budgets

Communicates with sponsors as the key contact with regard to statistical programming issues.

Communicates with DMs and Statisticians on programming related items.

Oversights project process, ensures that SOPs/WIs are followed.

Develops/Maintains central macro library

Trains new staffs

Maintains SOPs/WIs

Optimizes the working process

Leads or supports enhanced or new solutions to meet business need

Coordinates the development and implementation of Standard Operating Procedures and Working Instructions Documents.

Interacts extensively with a multi-disciplinary senior management team to identify critical needs and develop strategic initiatives.

Leads team

Mentors team members

Recruits new members

Tasks/Time estimation

Business Presentation

CDISC Implementation consultation

Programming Process consultation

Education & Experience Requirement

大学或学院的专业学位或以上：生命科学、计算机科学、数学、统计、生物统计、编程、药学或相关专业，或者在相关专业领域或认证机构获得的证书，如护理认证、计算机科学、医学或者实验室技术等。

行业工作年限5– 7+年

项目管理经验年限3–5+年

University/college degree or above (life science, computer science, mathematics, statistics, biostatistics, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)

Years of industry experience: 5–7+years

Years of project management experience:3–5+years

Key Competency Requirement

熟悉GCP/ICH指南，GCP=药物临床试验质量管理规范，ICH=人用药品注册技术要求国际协调会议。

熟练/精通SAS

SQL (a plus)

VB或其它计算机脚本语言(a plus)

C# (a plus)

XML (a plus)

关系型数据库

CDISC CDASH/SDTM/ADaM数据标准

CDISC ODM, define.XML及其它数据标准

英语口语和书面英文流利

团队合作能力良好

沟通交流能力良好

快速学习能力良好

演讲能力良好

项目管理能力良好

解决问题能力良好

对团队的影响力良好

GCP/ICH guidelines

SAS

SQL (a plus)

VB/Other computer language (a plus)

C# (a plus)

XML (a plus)

Relational Database

CDISC CDASH/SDTM/ADaM data standard

CDISC ODM, define.XML and other data standards

English, written and verbal

Teamwork

Communication skills

Quick learner

Presentation skills

Project management

Problem Solving skills

Influence to others

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

上班地址：上海市浦东新区祥科路298号佑越国际，3楼301-305