Job Description :
Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures.
Review and provide feedback on deliverables from other clinical groups including but not limited to: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms.
Clear and proactive communication with Study / Project teams to clarify requirements and specifications, update others on assignment status, and to convey data irregularities.
Provide active support on planned initiatives that facilitate infrastructure and process enhancements within Biometrics.
Provide support for ongoing regulatory and safety reporting.
Train and mentor junior programmers.

BS or equivalent relevant education and 5+ years or MS/PhD and 3+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education.

Experience with oncology clinical studies.
Experience implementing CDISC standards.
Experience with regulatory submissions (e.g. BLA, NDA, NDS, MAA, etc
Experience with additional programming languages and tools such as S-Plus, R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS.
Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area.
Good written and verbal communication skills.