Senior Statistical Programmer/Analyst (Boston, MA)

Under minimal supervision, the SeniorStatistical Programmer/Analyst will be responsible for developing and managing SAS programs to generate tables, listings, graphs and datasets for clinical study reports and submissions of data to global regulatory agencies. This position will also be responsible for developing standard reporting tools for general use by the Biostatistics department.

CRITICAL PERFORMANCE AREAS:

• Create and manage programs generating data tables, listings, and figures
• Develop and implement standard reporting tools and techniques
• Contributes to SOP development and process improvement efforts
• Act as an integral member of the clinical research project team
• Ensure accuracy of data reporting through program validation and document review

• Create and manage programs generating data tables, listings, and figures
• Program standard reporting tools for general use by Biostatistics department
• Follow good programming practices and adequately document programs
• Create and maintain file structures for storing clinical data and associated programs
• Prepare clinical data for electronic submission
• Validation/QC
• Contribute to SOP development and process improvement efforts
• Review final study reports and other publications for accuracy
• Act as an integral member of the clinical research project team
• Review and provide feedback on CRFs, database specifications and data validation plans
• Train and mentor new departmental employees (if applicable)
• Keep informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings
• Be familiar with FDA regulations that affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions

Minimum Requirements

• BS Degree in computer science, mathematics, statistics, life science or related field
• At least 5-8 years of demonstrable proficiency in programming and data manipulations using SAS software in medical research field
• Demonstrates expertise in SAS Base, SAS Stat, SAS Graph, and SAS Macro
• Demonstrates expertise in working with clinical or epidemiological data
• Demonstrates expertise in computer program documentation and validation
• Demonstrates expertise with basic data and file structures
• Excellent written and oral communications skills
• Excellent planning and organizational skills
• Ability to work independently as well as within teams

• Knowledge of relational databases and Oracle Clinical TM
• Previous experience with electronic submissions and CDISC requirements.

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