New · posted Nov 14
AbbVie · Pharmaceuticals
Manager, Clinical Data & Reporting Standards - SDTM Programming
- Florham Park, NJ +3 more
- Hybrid
- Full-time
- Manager
The role
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.
What you need
Two ways to qualify
Master’s
+ 8 years of experience
MS with 8 years of relevant experience, OR
- or
Bachelor’s
+ 10 years of experience
BS with 10 years of relevant experience
Minimum Qualifications
- 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 Experiencenice to have
- 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$110,000 – $209,000 a year
Employer providedPaid time off
Medical/dental/vision insurance
401(k)
Long-term incentive programs
Where you'll work
Florham Park, NJ +3 moreHybridOpen in Maps (opens in a new tab)
Also posted for: North Chicago, IL · Irvine, CA · South San Francisco, CA
More jobs in Florham Park, NJ +3 more
From the posting
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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 applicants seeking a reasonable accommodation, click here to learn more:
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Clinical Data Management roles at this level.
This roleEmployer provided
Manager roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $209,000 |
| All US (middle half) | $152,250 | $159,500 | $181,000 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 63 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct2
- Documentation and SOPs1
- Regulatory submissions1
- Collaboration and leadership1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA requireNamed in the posting
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
Company hiring pulse
AbbVie on Regulatory Jobs
- 72
- Open roles
- 72
- Distinct roles
- 16
- Locations
By discipline
- Clinical60 52%
- Quality29 25%
- Regulatory27 23%
By level
- Director51 44%
- Manager35 30%
- Senior & Principal16 14%
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Manager, Clinical Data & Reporting Standards - SDTM Programming at AbbVie
Open until filled. $110K–$209K a year, employer provided.