Job Description :
Role : Statistical Programmer (w/ SAS exp
Location : Chicago, IL
Job duration: Long Term
MOI : WebEx/skype
Please check with candidate this skills
knowledge on ADaM datasets (safety and efficacy)
- safety domain knowledge.
- basic concepts such as Merging, Baseline
- output creation.
Oncology exp
Responsibilities:
Demonstrated practical understanding of SDTM data sets creation and SAS programming concepts and techniques appropriate to the pharmaceutical industry.
Demonstrated satisfactory ability to apply SAS programming knowledge to solve problems related to non-routine situations.
Ensure internal consistency of output and assess consistency with other activities for the project, as applicable.
Follow all department and project standards.
Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities.
Responsible for ensuring peer review has been completed for all activities for the assigned projects.
Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies.
Review for consistency across studies within a project.
Ensure accuracy of database quality assurance checks and assess data accuracy and consistency.
Develop database checks for routine and with supervision develop checks for non-routine situations.
Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
Responsible for the creation and accuracy of derivation programs for routine and with supervision create derivation programs for non-routine situations.
Responsible for ensuring peer review has been completed for all derivation programs for assigned projects.
Responsible for the creation and accuracy of submission data sets and analysis programs for routine situations and with supervision for non-routine situations.
Responsible for the creation of data definition documents and TOCs.
Responsible for ensuring peer review for all submission data sets and programs for the assigned projects.
Minimum Requirements:
MS in Statistics, Computer Science or a related field with 5+ years of experience in efficacy programming.
High degree of technical competence and communication ability, both oral and written.
Competent in SAS programming and Macro development.
Pharmaceutical or related industry experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.