Manager, Data Standards
Manager, Data Standards
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Manager Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVies portfolio of clinical trials and ensures AbbVies conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include
Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
o SDTM mapping
o Data Collection
o Data Review Rules
Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
o Study-level tables listings or figures
o Product-level safety analysis displays
o ADaM mapping and derivation
Ensuring each standard is clearly defined with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards SDTM standards align with ADaM standards etc.)
Develop training materials to the organization on the proper use of standards in pipeline activities
Communicate ongoing standard development activities across the organization
Pipeline responsibilities include
Create review and provide feedback on SDTM Mapping Specifications and Trial Design Domains
Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH SDTM and ADaM) and AbbVie standard extensions to CDISC
Oversee the creation of SDTM annotated CRF and Clinical Study Data Reviewers Guides for both FDA and PMDA submissions
Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata or by providing an appropriate explanation
Other responsibilities include:
Representing AbbVies interests in industry standards development projects
Staying current with industry standards such as CDISC and the regulatory requirements related
to their use
Identifying improvements to the processes and content of standards and driving those
improvements to completion
Mentor junior team members
Qualifications :
This is a remote opportunity that can be hired anywhere in the US
Experience leading development of standards for data collection tabulation analysis and/or
reporting
Experience with SDTM is required
Experience with CDASH is highly recommended
Experience with ADaM Analysis Results Metadata or TLF standards is helpful
Active participation in CDISC teams preferred
Experience with preparing SDTM datasets and documentation for regulatory submissions
Education and experience requirements
MS with 8 years of relevant clinical research experience or
BS with 10 years of relevant clinical research experience
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $106500 - $202500
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
