Location: Miami, FL

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$90,000-$130,000

The Statistical Programming Consultant is a skilled scientist with training and significant experience in programming report tables for drug development and clinical research. The Statistical Programming Consultant needs to be knowledgeable about appropriate software and tools to perform his or her tasks including primarily familiarity with SAS. He or she is expected to work collegially and closely with biostatisticians as well as clinical research staff and others to produce report tables, figures, and listings for clinical studies as well as help with additional requests. He or she must have excellent written and oral communication skills.

Essential Functions:

• Read and understand the SAP and protocol.
• Prepare SDTM and ADaM datasets as required by the SAP and the output verification plan following applicable standards.
• Prepare documents for derived datasets with list of required derived variables and code the derived datasets.
• Review edit check document prepared by data management. Create edit check code.
• Provide data management with data issues discovered during programming work
• Prepare mock tables for SAP under the direction of the study statistician.
• Write programs to create tables, figures, and listings for clinical study reports
• Review programs, verify the output and provide comments.
• Assist statistician as needed with statistical efficacy programs.
• Produce in-text figures for clinical study report.
• Prepare pdf documents containing the tables, listings and figures.
• Prepare the data documentation needed for submissions to the FDA.
• Review clinical study report. Review report and compare results to the results in the tables.
• Adhoc requests from various sources may be for currently assigned studies or other studies.



Requirements:

• B.S/B.A. in Statistics/Biostatistics (or related field), with a minimum of 2 years of experience, is required.
• Good presentation and written communications skills.
• Good organizational and problem-solving skills.
• Ability to program proficiently using SAS
• Knowledge of coded terms for the adverse events and concomitant medication datasets from MedDRA and WhoDrug dictionaries, respectively.
• Knowledge of CDISC SDTM and ADaM
• Knowledge of relevant FDA and CHMP guidelines
• Experience with regulatory submissions in the US and EU desirable