AbbVie

Associate Director, Clinical Data & Reporting Standards - Oncology Focus

Employer
AbbVie
Location
Lake County, Illinois
Posted
Nov 18, 2021
Ref
2119456
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Multiple locations – Lake County IL (preferred), South San Francisco CA, Madison NJ or remote 
Clinical Data and Reporting Standards
Associate Director (Grade 20) – Oncology focus
The Associate Director, Clinical Data and Reporting Standards (CDARS) proactively drives forward the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials, continuously scanning the regulatory landscape and ensuring AbbVie’s conformance to CDISC standards and industry best practices.  In collaboration with the Head of CDARS, he/she sets the strategy and framework for governance of standards and actively engages in deployment of next generation process and technology.  This role will focus on CDASH and SDTM standards within the Oncology Therapeutic Area.
Standards Development responsibilities include
•    Leading a cross-functional team of subject matter experts to define one more of the following types of standards within the immunology therapeutic area or across therapeutic areas (e.g. immuno-oncology standards):
o    Data Collection
o    Data Review Rules
o    SDTM mapping
•    Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the oncology therapeutic area or across therapeutic areas (e.g. immuno-oncology standards):
o    ADaM mapping and derivation
o    Study-level tables, listings, or figures
o    Product-level safety analysis displays
•    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.)
•    Educate the organization on the proper use of standards in pipeline activities
•    Communicate ongoing standard development activities across the organization
Pipeline responsibilities may include
•    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
•    Review and provide feedback on SDTM Trial Design Domains
•    Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s 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 AbbVie’s 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
•    Manage 3 or more direct reports
 


Qualifications

Qualifications 
•    Experience leading development of standards for data collection, tabulation, analysis and/or reporting
•    Experience with CDASH and SDTM
•    Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful
•    Active participation in CDISC teams preferred
•    Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
•    Experience with standards related to oncology 
•    Experience with standards related to immunology, eye care, neuroscience, virology, women’s health, medical aesthetics or devices is helpful
Education and experience requirements
•    MS with 10 years of relevant clinical research experience, or
•    BS with 12 years of relevant clinical research experience


Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.