Kelly Services Senior Principal Statistical Programmer - San Diego, CA in San Diego, California
Senior Principal Statistical Programmer - San Diego, CA
Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings TFLs shells.
Write SAS programs to generate derived analysis datasets ADAM-SDTM , perform analysis, and TFLs.
Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
Ensure consistency and adherence to standards within their therapeutic area.
Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
Oversee the services provided by CROs.
Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
Provide training on departmental SOPs/WPs and standard programs.
Contribute to the creation of naming conventions and standards for the programming environment.
Participate in industry wide technical discussions.
Bachelor s degree in life science, statistics, mathematics, computer science, or related field is required.
Master s degree is preferred.
8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelors degree; or 8 plus years experience with a MS/MA degree.
Demonstrated proficiency in using SAS to produce derived analysis datasets and produce 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 interpersonal, communication, writing and organizational skills.
For immediate consideration, apply today!
Questions? Call Elijah at 602.548.1774 or Email at Elijah.Bruder@kellyscientific.com
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AboutKelly Services ®
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