Assoc Dir, Data Operations

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POST DATE 9/2/2016
END DATE 11/16/2016

Eisai Woodcliff Lake, NJ

Company
Eisai
Job Classification
Full Time
Company Ref #
3823BR
AJE Ref #
576065612
Location
Woodcliff Lake, NJ
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
Department Name
Data Mgmt Neuro

Location/Territory Name
Woodcliff Lake, NJ

Job Description
The Eisai Neuroscience Group Business is currently looking to fill an Associate Director, of Data Operations opening at its North American Headquarters in Woodcliff Lake, NJ.
The individual should have expertise in addressing technical challenges that connect EDC, SAS, CDISC and XML.
Excellent technical skills in EDC and SAS systems and application development.
Experience in consulting on projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle at global level for both CRF standards and SDTM standards.
Experience in Review and Quality assurance of datasets and programming specifications produced by other programmers.
Experience in Accountability for development and maintenance of cross-functional / cross-department process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analyses and submissions. Responsible for implementing new technologies for end users and streaming the process from data collection to submission.

Scope and Responsibilities

- A highly specialized individual contributor or functional manager with advanced knowledge and expertise in a professional discipline.
- Leads execution of key business objectives or projects within the department.
- Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.

The individual must have the following skills:

Expertise in addressing technical challenges that connect EDC, SAS, CDISC and XML.
Excellent technical skills in SAS system and application development.
Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
Expert in integrating SAS with other leading technologies such as PDF, XML, Microsoft Office, to support electronic submissions.
Experience in consulting on projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle.
Experience in Annotating CRFs in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.
Experience in Reviewing and quality assurance of CRF annotations produced by other programmers
Embracing and contributing to our culture of process improvements with a focus on streamlining our processes adding value to our business needs.
Experience in Reviewing and quality assurance of datasets, programs and programming specifications produced by other programmers.
Accountability for development and maintenance of cross-functional / cross-department process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission.
Accountability for execution of process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission
Engaging appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM
Accountability for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets, with high quality and on time.
Providing SDTM data production technology to CDO (Clinical Data Operations) related to SDTM data delivery and manages the activities of a team with a common focus.

Job Qualifications
The individual must have the following skills:

Expertise in addressing technical challenges that connect EDC, SAS, CDISC and XML.
Excellent technical skills in SAS system and application development.
Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
Expert in integrating SAS with other leading technologies such as PDF, XML, Microsoft Office, to support electronic submissions.
Experience in consulting on projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle.
Experience in Annotating CRFs in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.
Experience in Reviewing and quality assurance of CRF annotations produced by other programmers
Embracing and contributing to our culture of process improvements with a focus on streamlining our processes adding value to our business needs.
Experience in Reviewing and quality assurance of datasets, programs and programming specifications produced by other programmers.
Accountability for development and maintenance of cross-functional / cross-department process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission.
Accountability for execution of process related to clinical trials SDTM data production, including specification, programming, QC, and deliverables of SDTM data for analysis and submission
Engaging appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM
Accountability for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets, with high quality and on time.
Providing SDTM data production technology to CDO (Clinical Data Operations) related to SDTM data delivery and manages the activities of a team with a common focus.

Auto req ID
3823BR

Job Type
Full-time



Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet