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Temporary Data Analyst

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POST DATE 9/17/2016
END DATE 11/15/2016

Cardionet Inc. Rockville, MD

Company
Cardionet Inc.
Job Classification
Full Time
Company Ref #
2016-2178
AJE Ref #
576203371
Location
Rockville, MD
Experience
Mid-Career (2 - 15 years)
Job Type
Temporary
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

Position Summary

The Data Analyst, under limited supervision, has responsibility for providing SAS programming and data management support for clinical research studies from start-up through final locked database. The Data Analyst participates in project initiation, conduct, and closing activities that include, but are not limited to, project-specific document preparation, internal and external team meetings, clinical trial site and customer communication, and on-going monitoring of the quality of data. The Data Analyst collaborates with other internal groups as well as customer data management representatives to ensure successful data delivery to the customer.

RESPONSIBILITIES:

Responsibilities:

* Writing programs of moderate to advanced complexity to support clinical research efforts

* Testing, debugging, revising, and refining SAS programs to meet specifications including but not limited to:

* Running and modifying active production programs and reviews for accuracy

* Constructing high quality code books and format files

* Ensuring results quality by adhering to established standards and procedures

* Performing activities necessary for file documentation and task management

* Maintaining programs, project files, audit trails, and data libraries

* Creating and maintaining associated documentation, including data flow diagrams and flow charts

* Contributing to the development and implementation of data transfer specifications

* Performing other ad hoc data management activities, including data transfers, backups, etc.

* Demonstrating excellent oral and written communication skills

* Complying with customer guidelines, and company Quality System Procedures, system development life cycle, system validation and systems change control related to data management and analysis

* Developing and implementing data standards, documents specifications and procedures

* Performing statistical analysis

* Collaborating with study personnel to provide input to statistical analysis plans

* Selecting statistical methods for data analysis, and conducting analysis once a reporting database is created

* Collaborating with other data management team members in the planning and implementation of data quality assurance plans

* Maintaining proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods

* Effectively justifying methods selected and implementing previously outlined analysis plans

* Effectively utilizing current technologies and available tools for conducting the clinical trial analysis

* Effectively communicating Results and Inferences

* The physical demands are representative of those an employee encounters while performing the essential functions of this job

QUALIFICATIONS:

Qualifications



Education:

* BA/BS degree in a technical, business or scientific discipline



Experience:

* Minimum 2-5 years of experience in Statistical SAS programming and data management programming in clinical research studies for clinical trials, preferably in a Clinical Research Organization (CRO), pharmaceutical or biotech environment

* Data analysis experience, particularly definition and specification of data structures, database design concepts and data output options

* Demonstrable experience in effective verbal and written communications and interaction with internal and external customers

* Experience in application of knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Quality System Procedures and customer expectations



Skills:

* Thorough understanding of clinical data management and statistical analysis processes through all phases of the clinical trial life cycle

* In-depth knowledge of programming languages like SAS / R including creating reusable SAS macros or R functions

* Knowledgeable about data and file structures, database design and output options

* Good knowledge of relational data bases/ clinical data management systems

* Ability to maintain a high degree of confidentiality with clinical data and customer proprietary data

* Attention to detail and data

* Excellent organization, analytical and problem-solving skills

* Ability to identify potential out of scope activities to project and data management

* Strong command of English language and grammar

* Proficient in the use of computer systems, including Microsoft Office applications such as Excel, Word, PowerPoint, Project, Visio

* Familiarity with applicable regulatory guidance and rules, e.g., 21 CFR Part 11, FDA Guidance

* Ability to successfully apply above skills, knowledge and abilities across a portfolio of studies or with a franchise customer

* Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

* Ability to recognize, evaluate and develop plans to mitigate project related risk

*CB

COMPANY:

Cardiocore Biotelemetry Research