Emmes Services Pvt. Ltd , ("Emmes") is searching for CDISC SAS Programmer in India . Emmes provides flexibility of working from home or for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing clinical operations, statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

A CDISC SAS Programmer works within Emmes' CDISC Service Group and is responsible for generation of CDISC-compliant data structures for clinical trials. The CDISC SAS programmer will map clinical data to SDTM domains and work with project teams to create and validate other CDISC materials necessary for regulatory submissions.

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Responsibilities

• Review protocols and CRFs for CDISC conformance
• Writes well-documented SAS code for mapping clinical data to SDTM data structures in conformance with CDISC SDTM Implementation Guides, Therapeutic Area User's Guides, project standards, and the study protocol
• Create Define specifications for mapping of SDTM compliant datasets
• Review and QC submission ready SDTM datasets, define.xml, and supporting documentation
• Prepare and validate submission packages (define.xml, Reviewer's Guide)
• Explain CDISC concepts to project staff
• Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
• Other duties as assigned

Experience

• Bachelor's degree (scientific discipline preferred).
• Minimum 4 years of experience is required. It will vary based upon education, knowledge, skills, and ability
• Demonstrated experience creating tables, figures and listings for clinical data.
• Competent in SAS software and extensions SAS Macro and SQL.
• Familiarity with Pinnacle21.
• Submission experience utilizing define.xml and other submission documents.
• Ability to manage multiple tasks.
• Ability to work independently, as well as in a team environment.
• Ability to effectively communicate technical concepts, both written and oral.

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.