Job Description

Responsibilities...
• The Sr. Statistical Programmer will be the lead programmer for multiple projects supporting clinical study reports and publications.
• Accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management.
• Responsible for producing programming outputs, validation, and related documentation. Responsible of designing, developing, maintaining, and validating (SAS) computer programs to derive, store, analyze and report clinical trial data.
• Ensure deliverables meet expectations in timelines and quality; regulatory and key user groups (e.g. CDISC) requirements; operational efficiency; alignment with study clinical and statistical objective.
• Produce TLFs under direction of biostatistician.
• Design and maintain statistical datasets that support multiple stakeholder groups.
• Map and/or pool raw datasets into derived and analysis datasets
• Provide input into SAP, analysis specifications and data presentations for clinical trials.
• Programming validation utilizing global standards, following departmental SOPs and good programming practices.
Requirements:
• Bachelors, with excellent track record in mathematics, statistics, informatics.
• 6+ years of experience as a statistical programmer on several concurrent projects with basic project management. (Life Science industry background is strongly desired.)
• Advanced experience with SAS is required.
• Familiar with international guidelines, industry standards, Good Programming Practices and internal quality procedures.
• Knowledge and experience in SDTM and ADaM.
• Previous experience in procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH is desired.
• Track record of successful submission activities and project or team lead experience, preferred.
• Expert in application of "state-of-the-art" programming methodology in the projects under responsibility
Houston TX USA

Salary Criteria