| Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. |
Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
Perform programming validation to ensure quality of analysis datasets and programming outputs.
Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
Create Data Definition Tables (DDT) and convert TFLs to the required format for eSubmission.
Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
Contribute to the creation, maintenance, and validation of standards for outputs and macros.
Bachelor s degree in life science, statistics, mathematics, computer science, or related field required; Master s degree is preferred.
5 plus years Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions.
Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
Have in-depth understanding of clinical data structure and relational database.
Demonstrated skills in using software tools and applications, e.g., MS office, XML.
Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
Have in-depth understanding of regulatory, industry, and technology standards and requirements.
Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
Demonstrated ability to work in a team environment with clinical team members.