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IT Elite Inc is looking for Senior SAS Clinical Programmer / Lead to work on a long term assignment with our client.

Remote & W-2 opportunity.

Roles and Responsibilities

• Develop SAS programs that generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.
• Develop SAS programs that support regulatory requests, ISS/ISE analyses, commercial requests, and biostatistical ad hoc analysis.
• May have to create SAS utility macros; write and implement test plans to support SAS macro development.
• Review and validate CRO deliverables.
• Lead and oversee programming activities performed by CRO programming and biostatistics team.
• Review SDTM and ADAM specs, datasets, define, and reviewers guide for multiple studies.
• Perform quality review on SAS programs generated by other statistical programmers.
• Help solve critical issues requiring SAS expertise.
• Understand and follow FDA regulations that affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Keep informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.
• Assist in other programming tasks using software other than SAS (e.g. SQL) to support specialized data analysis requirements.
• Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines.

Experience, Education and Specialized Knowledge and Skills
• 8+ years of experience in the pharmaceutical industry.
• 10+ years of excellent SAS programming skills and extensive experience working with BASE SAS, SAS GRAPH, and SAS macro programming.
• Enjoy working collaboratively as part of a team.
• Be capable of handling multiple priorities.
• Adapt to changing priorities; take initiative and follow through on own
• Be attentive to detail and able to independently resolve a variety of issues without close supervision.
• Be an independent creative thinker.
• Excellent interpersonal skills.
• Be able to manage multiple projects/tasks and appropriately prioritize.
• Be able to oversee programming work performed by Contract Research Organizations.
• Proficiency in statistical procedures(e.g., PROC FREQ, PROC REPORT, PROC GLM, and PROC MIXED).
• In-depth knowledge of CDISC standards for SDTM, ADaM, and FDA electronic data submission requirements.
• Submission experience (including review of Defines/aDRGs).
• Understanding of SAS database structures and experience with at least one Clinical Database Management System (e.g. Medidata RAVE, Oracle inform, etc.).
• Excellent communication skills (verbal, written, and interpersonal).
• Regulatory submission programming is a plus.
• Ability to work well within multi-disciplinary teams and proven ability to coordinate and drive projects in a matrix organization.

If your skills match the above requirement, Please forward your resume as a word attachment along with your contact numbers and salary requirements.