Clinical Programming Manager

Cogent Infotech • United States, United States • 1w ago

About Cogent Infotech At Cogent Infotech, we believe in creating opportunities that empower individuals and transform organizations. With over 21 years of excellence in consulting and talent solutions, we pride ourselves on building inclusive workplaces and driving innovation in everything we do. Our diverse teams bring unique perspectives to help deliver cutting-edge solutions to global clients across both public and private sectors.

Cogent is parterning with a global pharmaceutical company for hiring a Clinical program manager in Westchester, PA. Shift Schedule: Morning - US time zone 8 hours/day â?? preferably East Coast Core essential skill sets candidates must have to be considered for the role: 1. Minimal Bachelorâ??s degree in any field 2. Minimal 5 years experience with Clinical data, SDTM IG, and Pinnacle 21. Screenings: 1. Background: Basic Bkg 2. Drug: 11 Panel + Fentanyl Position 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. Travel Requirements: Limited as job tasks are required Essential Duties & Responsibilities: 1. Provides input for Budget Planning 2. Likely to oversee contingent workers and/or vendors; Likely to provide training to others 3. Primarily works at the project level 4. Delivers assignments with quality and within timelines 5. Contributes strategy under moderate supervision 6. 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 7. Has good knowledge and understanding of the statistical models in efficacy data analysis 8. Responsible for the standardization of Clinical Programming deliverables within a project 9. Extends existing or develops new clinical programming methods to solve complex problems Position Requirements: Education Required: Bachelorâ??s Degree/ Masterâ??s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience. Experience Required: Bachelorâ??s + 5 years or Masterâ??s + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer Experience Preferred: Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements. Specialized or Technical Knowledge Licenses, Certifications needed: 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: 1. Contributes to strategy under moderate supervision 2. Tackles difficult problems; identifies solutions and recommends action to management 3. Influences communication toward common understanding and actionable results; contributes to process and development 4. Ability to effectively work in a global environment 5. Ability to effectively interact with and influence others without direct reporting relationships

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