Senior Manager Data Standards Remote
Senior Manager Data Standards Remote
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior 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 crossfunctional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
- SDTM mapping
- Data Collection
- Data Review Rules
- Participating in a crossfunctional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
- Studylevel tables listings or figures
- Productlevel safety analysis displays
- 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 9 years of relevant clinical research experience or
- BS with 11 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.
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 shortterm 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:
No
Employment Type :
Fulltime
Employment Type
Full-time
