Jobs › AbbVie

Manager - Data Standards, SDTM Programming (Hybrid)

AbbVie · North Chicago, IL · Full time · Other

Posted Sep 9, 2026 · We last checked this listing on Oct 6, 2026

Apply at AbbVie

Likely interview questions for this role

Written from this job description, not a generic list. Each one notes what the interviewer is really checking.

About your past

You'd document assumptions and decisions behind each standard. Why does that matter years later?

What they are checking: Whether they see documentation as protection for future reuse and inspections, since years later nobody remembers why a mapping decision was made.

You'd develop training materials. How do you teach a standard so programmers apply it consistently?

What they are checking: Whether their training actually produces consistent work from programmers, because a standard only has value if people apply it the same way every time.

What would you do

How do you get a cross-functional group of subject matter experts to agree on one standard?

What they are checking: Whether they can bring experts with strong opinions to a single agreed standard, because consensus building is the real daily work of this job.

A study team wants to deviate from a standard. How do you handle that?

What they are checking: Whether they can hold a standard firmly while granting genuine exceptions, because standards that never bend get bypassed and ones that always bend mean nothing.

This is a hybrid role based at North Chicago. Does that arrangement work for you?

What they are checking: Whether the stated hybrid schedule at North Chicago genuinely works for them, so there are no surprises about expected days on site later.

About the work

This role develops clinical data and reporting standards including Study Data Tabulation Model mapping. Walk me through how you'd define a mapping standard for a therapeutic area.

What they are checking: Whether they can create standards from scratch rather than just apply existing ones, since this role defines how every downstream study maps data.

The posting names data review rules. What makes a good review rule, and what makes one that just generates noise?

What they are checking: Whether they design review rules that catch real problems without flooding programmers with false alarms, since noisy rules get ignored quickly.

How do you ensure the case report form standards, tabulation standards and analysis dataset standards stay aligned with each other?

What they are checking: Whether they keep collection, tabulation and analysis standards consistent end to end, because a mismatch anywhere breaks traceability in a regulatory submission.

How do you decide what belongs in a product-level safety display versus a study-level table?

What they are checking: Whether they understand how integrated safety displays differ from study tables, a specific judgment this role makes for submissions across a whole product.

How do you keep standards current as regulatory expectations change?

What they are checking: Whether they track changing regulatory and industry expectations and update standards in a controlled way, since outdated standards create submission risk.

Practice this interview out loud.

Offer builds a real interview for this exact role at AbbVie from your resume and this job description, asks the questions one at a time, and tells you what landed. The first one is free.

Practice this out loud

The full job description

As published by AbbVie.

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 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 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. 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 https://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, visit https://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

Apply at AbbVie