Manager - Data Standards, SDTM Programming (Hybrid)

BioSpace; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Manager, Clinical Data and Reporting Standards (CDARS) who will help develop data and reporting standards for clinical trials and ensure CDISC conformance across SDTM/ADaM. You will implement governance frameworks and drive next-generation processes and technology.

The role involves cross-functional collaboration, creating documentation, training materials, and communicating standard development activities to the organization, with opportunities to influence

Qualifications

• SDTM programming experience required.
• Experience developing data collection, tabulation, analysis or reporting standards.
• Experience preparing SDTM/ADaM datasets and regulatory submission documentation.

Responsibilities

• Develop and define data standards (data collection, review rules, SDTM mapping).
• Define ADaM mapping, study tables, listings or figures, and safety analysis displays.
• Ensure standards are well documented with assumptions and decisions.
• Create training materials and communicate ongoing standard development activities to the organization.
• Ensure consistency across SDTM/ADaM/CDASH standards and related processes.

Skills

SDTM programming

Standards development

Regulatory submissions

Education

MS in relevant field

BS in relevant field

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 ensuring AbbVies 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 specificationsOversee the creation of SDTM datasets, define.xml, 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

Minimum Qualifications

• MS with 8 years of relevant clinical research experience, or
• BS with 10 years of relevant clinical research experience
• Experience with SDTM programming 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html