Statistical Programmer

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