Responsibilities
1)Develops SAS programs to produce data listings and Case Report Form Tabulations
(CRT) as by domain or by subject
2)Builds standard tabulation datasets according to certain industry standard or the client’s
requirements
3)Creates derived or analysis datasets according to certain industry standard or the client’s
requirements based on the statistical analysis plan
4)Reviews the standard tabulation datasets and/or analysis dataset development
specifications and SAS programs created by other SAS programmer(s)
5)Develops SAS programs to implement statistical analyses and generate tables, listings
and figures as specified in the statistical analysis plans
6)Performs validation of and quality assurance aspects of all SAS programming activities
7)Supports for regulatory submission (e.g. NDA and PMA) including submission datasets
preparation
8)Develops SAS programs for other needs
9)Represents SAS programming team at project team meetings and provides s to
project team on status of tasks
10)Communicates with project team members such as Project Biostatistician, Data Manager,
and Project Manager regarding project issues
11)Communicates with client regarding SAS programming issues
12)Ensures integrity of all systems by preserving security and following change control
procedures
Participates in department level applications such as SAS Macro Library Development
13)Consults on other statistical programming tasks, such as support for CRF design,
database development, data validation plan and blinded data review
14)Consults on SAS program design strategies and provides technical support to
programming team
15)Mentors and trains low level biostatisticians and new colleagues
16)Performs other duties assigned by supervisor
Qualifications
1)Bachelor degree in a scientific or technical area (statistics or related subjects is preferred);
An advanced scientific degree is desirable
2)Knowledge of programming methodology; a high degree of skills in the management and
resolution of SAS programming issues
3)At least 3 years (for bachelor) or 2 years (for or above) experience with Base SAS
(data step programming), SAS/SQL, SAS/MACRO, SAS/ODS, SAS/GRAPH,
SAS/ACCESS and SAS/STAT. ISS/ISE experience is a plus
4)Experience with the CDISC data standards and clinical database setup is preferred
5)Experience of international drug development in a multicultural environment is a plus
6)Ability to deal with sensitive inquiries or complaints clients or potential clients and
to protect confidentiality
7)Demonstration of ethical leadership skills and exhibit high moral acter so as to foster
respect for ethnic and religious diversity and support equal opportunity for all employees
based on demonstrated ability and to exhibit a high degree of skills in the management
and resolution of conflict
8)Knowledgeable in all aspects of the drug agencies (e.g. FDA) regulations and
requirements governing the conduct of drug, biologic and device studies including, but
not limited to, GCP and ICH requirements
9)Excellent communication and interpersonal skills
10)Able to make effective presentations in public settings
11)Proficient working in a PC/Windows environment
12)A good command of English language if one’s native language is not English
招聘单位:依格斯(北京)医疗科技有限公司
工作地点:上海
简历投递:
resume.tbc@excel-cro.com