Job Title:  Sr. Contract Oncology SAS Programmer

Location:   TELECOMMUTE

Assignment Duration:  6 month extendable, will go 1 year +

 Job Responsibilities:

• Coordinate all programming activities for the project team including those for study reports, regulatory submissions, publications and informal requests
• Independently write programs for the creation of analysis datasets, pooled datasets, listings, tables and figures for clinical trials
• Provide input and review to statistical analysis plans, CRFs, and dataset structures
• Develop and comply with programming standards and specifications
• Programming tumor response related efficacy endpoints for phase II or III oncology clinical trials
• Support quality control and quality audit of deliverables
• Establish systems for documentation and archival of programming work.

 
Requirements:

• Bachelor’s or Master's degree in Statistics, Biostatistics, Computer Science or equivalent work experience
• At least 5 years of experience using SAS in the pharmaceutical or biotech industry
• At least 2 years of experiences programming tumor response related efficacy endpoints for phase II or III oncology clinical trials
• Candidate must have Lead/Team Lead experience in a programming environment  
• Expertise in SAS/BASE, SAS/STAT, SAS/MACRO
• Competence with SAS/GRAPH, SQL
• Experience with regulatory reporting and submissions; involvement in NDA or BLA is preferred
• Understanding of regulatory requirements and considerations (e.g. GCP, ICH, 21CFRpart11, CDISC)
• Excellent organizational, technical, and interpersonal skills
• Ability to work independently and act with initiative to address issues
• Conscientious and efficient approach to program writing, validation and organization