Clinical Programming Manager

Job Summary:

• The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
• The Manager leads and manages completed projects that involve global tasks, cross functional teams, or outsourcing resources.
• The role may require providing input to design and analysis, and report the results of clinical trials, including programming rules and mocked T/L/G.
• In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.

Essential Duties & Responsibilities:

• Provides input for Budget Planning
• Likely to oversee contingent workers and/or vendors; Likely to provide training to others
• Primarily works at the project level
• Delivers assignments with quality and within timelines
• Contributes strategy under moderate supervision
• Provides strong programming support to CDISC based e-submission.
• Develop, review, and/or perform validation of generic macros.
• Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets
• Has good knowledge and understanding of the statistical models in efficacy data analysis
• Responsible for the standardization of Clinical Programming deliverables within a project
• Extends existing or develops new clinical programming methods to solve complex problems

Education and Experience:

• Bachelor’s Degree/ Master’s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
• Bachelor’s + 5 years or Master’s + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
• Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.

Functional Knowledge:

• Advanced level of SAS programming skills.
• Develop SAS programs and perform QC tasks for integrated analysis.

Company/Industry Related Knowledge:

• Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.

Job-Specific Competencies:

• Contributes to strategy under moderate supervision.
• Tackles difficult problems; identifies solutions and recommends action to management.
• Influences communication toward common understanding and actionable results; contributes to process and development.
• Ability to effectively work in a global environment.
• Ability to effectively interact with and influence others without direct reporting relationships.