Kelly Services Senior Principal Statistical Programmer - San Diego, CA in San Diego, California

Senior Principal Statistical Programmer - San Diego, CA

Responsibilities:

  • 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.

Skills/Knowledge Required:

  • 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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You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

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