The Statistical Programmer II (“Programmer”) will have experience in all required areas of a Statistical Programmer I. The Statistical Programmer II is responsible for providing programming support for clinical trials.

Essential Duties and Responsibilities:

Responsibilities

• Exceed expectations and responsibilities of a Statistical Programmer I
• Understand and implement CDISC and other regulatory standards
• Follow internal SAS programming conventions
• May serve as programming lead with responsibility for coordination of activities and timelines
• May prepare programming specifications for SDTM, ADaM and other derived datasets
• Apply knowledge of SAS programming to program/develop and/or validate statistical outputs according to the statistical analysis plan and other specifications; including but not limited to:
  • SDTM, ADaM or other derived datasets
  • Tables, listings and figures
• Review and provide input on case report form design
• Work effectively with other programmers, statisticians, data managers, database programmers and other cross-functional team members to ensure accurate and high-quality statistical outputs

Standard Operating Procedures (SOPs)

• Strong understanding of departmental and company procedures; ability to guide others on procedures

Additional Responsibilities

• Perform other duties as requested by management

Qualifications

• Education: The ideal candidate should have a degree in Statistics, Computer Science, or a closely related field or equivalent combination of education and experience.
• Experience:
  • Minimum of 2 years direct SAS programming experience in pharmaceutical development or CRO environment
  • Good knowledge of medical terminology and conduct and analysis of clinical trials
  • Knowledge of relevant industry data standards (e.g. CDISC SDTM, ADaM, etc.)
  • Excellent oral and written communication skills, organizational skills, and attention to detail are required

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).