JOB SUMMARY

This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements

JOB RESPONSIBILITIES

• Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management.
• May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Assists with the transfer of deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.QUALIFICATION REQUIREMENTS

• Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience.
  
• Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements.
  
• Knowledge and experience in the use of SDTM guidelines to build datasets.
  
• Proficiency in programming in SAS or other required software, preferably in a clinical trial environment.
  
• Excellent written and verbal communication skills.
  
• Ability to read, write, speak, and understand English.