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DR VINCE CLINICAL RESEARCH PA

Statistical Programmer

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Job Description

Statistical Programmer

DR VINCE CLINICAL RESEARCH PA

Overland Park, KS Job Details 1 day ago Qualifications Statistics Clinical research Statistics SAS SAS language SQL Master of Science CDISC standards Regulatory submissions Data analysis software Full Job Description

JOB TITLE

Statistical Programmer, Biostatistics

REPORTS TO

Executive Director, Clinical Trial Services

DIRECT REPORTS

Not Applicable

POSITION SUMMARY

The Lead Programmer provides expert statistical programming support for clinical studies in accordance with applicable regulatory requirements and standard operating procedures (SOPs).

KEY RESPONSIBILITIES

Act as programming team leader, managing the timelines and deliverables for the study

• Create, test, and document Statistical Analysis Software (SAS) programs for SDTM, ADaM, and TLFs according to the Statistical Analysis Plan (SAP) and other specifications Conduct Quality Control (QC) review of statistical documents and SAS output Develop SOPs and guidelines for the Biostatistics department Develop SAS macros or tools to increase efficiency

REQUIRED QUALIFICATIONS

MS in biostatistics or related field 3+ years clinical research experience in pharmaceutical/biotech industry Extensive knowledge of

SAS/STAT, SAS

Macro, SAS/SQL, SAS/GRAPH Good understanding of regulatory data submission and CDISC requirements Organizational and analytical skills with ability to multi-task and prioritize work

PREFERRED QUALIFICATIONS

Not Applicable