San Diego Senior SAS programmer opening (contract) -
Company: SimulStat's client
Location: San Diego
Posted on: October 12, 2018
Onsite - San Diego12 month renewable contract Responsibilities will include, but are not limited to, the following:
--- 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 the quality of analysis datasets and programming outputs.
--- Ensure consistency and adherence to standards within the project.
--- 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 converting 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 the lead programmer in support of NDAs, sNDAs.
--- Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
--- 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.
--- Provide training on SOPs, WPs and standard programs.
--- Contribute to the creation of naming conventions and development of the programming environment.
--- Oversee the services provided by CROs.
--- Bachelor's Degree in life science, statistics, mathematics, computer science, or related field is required; Master's Degree is preferred.
--- 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
--- Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
--- Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
--- Demonstrated skills in using additional software tools and applications (e.g.MS office, XML).
--- Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
--- Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
--- In-depth understanding of regulatory, industry, and technology standards and requirements. --- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
--- Demonstrated ability to work in a team environment with clinical team members.
--- Good planning and project management skills. --- Good interpersonal, communication, writing and organizational skills.
Keywords: SimulStat's client, San Diego , San Diego Senior SAS programmer opening (contract) -, IT / Software / Systems , San Diego, California
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