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Company

Original Job Post

AbbVie · 2 days ago

Senior Manager, Data Standards

Robbinsville Township, NJ

Full-time

Onsite

Senior Level

9+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Leading or participating in the development of data and reporting standards in the assigned therapeutic area

Educating the organization on the use of standards in pipeline activities

Providing feedback on CRF design and SDTM datasets to comply with CDISC standards

Overseeing the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for regulatory submissions

Representing AbbVie’s interests in industry standards development projects

Identifying improvements to standards processes and content

Qualification

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CDASHSDTMADaMAnalysis Results MetadataTLFCDISCADaM datasetsRegulatory submissions

Required

Experience leading development of standards for data collection, tabulation, analysis and/or reporting

Experience with at least two of the following standards: CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards

Active participation in CDISC teams preferred

Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

MS with 9 years of relevant clinical research experience, or

BS with 11 years of relevant clinical research experience

Benefits

Paid time off (vacation, holidays, sick)

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Long-term incentive programs

Company

AbbVie

Glassdoor

3.9

AbbVie is a pharmaceutical company that discovers, develops, and markets medicines.

Founded in 2013

North Chicago, Illinois, USA

10,001+ employees

http://www.abbvie.com

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (155)

2022 (299)

2021 (194)

2020 (197)