AbbVie

Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)

AbbVie • $110K — $140K *
Irvine, CA 92620Hybrid
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • MS with 8 years of relevant clinical research experience, or BS with 10 years
  • Experience with SDTM is required
  • Experience leading development of data standards
  • Experience with preparing SDTM and/or ADaM datasets for regulatory submissions
  • Experience with industry standards such as CDISC is preferred

Responsibilities

  • Participate with a cross-functional team to develop data collection and review standards
  • Ensure standards are well-defined and documented for pipeline support
  • Develop training materials on the use of clinical data standards
  • Communicate standard development activities within the organization
  • Provide feedback on CRF design to ensure regulatory compliance
  • Oversee the creation of SDTM datasets for submissions
  • Identify process improvements for standards and drive completion

Benefits

  • Comprehensive package of benefits including paid time off
  • Medical/dental/vision insurance
  • 401(k) for eligible employees
  • Long-term incentive program eligibility
Full Job Description
Job Description

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie's portfolio of clinical trials and ensuring AbbVie's conformance to CDISC standards and industry best practices as well as pipeline based SDTM development. 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:
    • Data Collection
    • Data Review Rules
    • SDTM mapping
  • 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:
    • ADaM mapping and derivation
    • Study-level tables, listings, or figures
    • 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.)
  • 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
  • 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
  • SDTM Programming based on SDTM specifications
  • Oversee the creation of SDTM datasets, 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


Qualifications

Minimum Qualifications:
  • MS with 8 years of relevant clinical research experience, or
  • BS with 10 years of relevant clinical research experience
  • Experience with SDTM is required
  • Experience leading development of standards for data collection, tabulation, analysis and/or reporting
  • Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

Preferred Experience:
  • Experience with CDASH is highly recommended
  • Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
  • Active participation in CDISC teams preferred


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 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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