– Onsite Preferred – San Diego; will consider remote for an ideal candidate
– 12 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.