PURPOSE OF THE JOB :

The position is responsible for the planning and execution of programming activities (development, quality control and documentation) in support of clinical project.


CORE JOB TASK

• Act as primary point of contact for all SAS programming activities.
• Plan programming deliverables.
• Oversee vendors’ programming deliverables.
• Develop SAS programs for SDTM, ADaM, Patient Profiles, Tables, Listings and Graphs of high complexity in support of Statistical Analysis Plan, posters, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Programming support for medical review listings and other activities need data summary and data mining.
• Drive programming activities to ensure quality and on-time deliverables.
• Good experience with regulatory submission.
• Review draft and final production runs for project to ensure quality and consistency.
• Represent Statistical Programming during vendor audits ensuring study documentation is maintained and filed according to DualityBio processes.
• Carry out all activities according to DualityBio SOPs and to Good Clinical Practice (GCP).
• Demonstrate expertise in technical/programming skills.
• Demonstrate knowledge of clinical trials activities.
• Demonstrate leadership skill.

Other Accountabilities & Tasks

• Perform other duties as requested by management.

MINIMUM REQUIREMENTS

• Education: Bachelor’s degree or above in computer science, statistics, mathematics or other scientific field (or equivalent theoretical/technical depth).
• ~5 years of experience programming and analyzing in a pharmaceutical/clinical trial environment.
• Fluent in written and spoken English.
• Easy-going.
• Knowledge of clinical trials and statistical methodology.
• Advanced SAS skills, Macro programming and SAS/STAT.
• Knowledge of regulatory requirement on drug development procedure and CDISC.

其他信息
语言要求：英语
行业要求：全部行业