Primary Function:

The Statistical Programmer II is responsible for all statistical programming aspects of clinical studies under supervision, related to statistical and clinical programming deliveries.

Major Responsibilities and Duties:

1)        Ensure timely and quality development and validation of medium and above complexity datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project

2)        Generation on e-data submission package following local regulation’s requirement

3)        Interact and communicate with Statisticians, Data Mangers, Clinical Operations, Medical Monitors and Medical Writers to develop and validation of customized outputs

4)        Comply with company, department and industry guidelines, Maintain supporting documentation for studies to ensure traceability and regulatory compliance

5)        Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents

6)        Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results

Qualifications:

1)     BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field.

2)     Proven skills in the use of SAS

3)     Well understanding on CDISC and regulation requirement to submission package

4)      Attention to detail

5)      Willingness and ability to learn and follow Company’s standard processes and procedures

6)      Demonstrate ability to learn new systems and functions

7)      Ability to successfully work together with a team as well as independently