Senior Analyst, Data Standards (Remote)

AbbVie Inc; North Chicago (IL); Remote; USD 70,000 - 110,000; Full time

Job summary

An innovative pharmaceutical company is seeking a dedicated professional to join their team. This role offers the chance to engage in meaningful work that contributes to the development of groundbreaking medicines. As part of a cross-functional team, you will ensure consistency in data standards and lead initiatives that drive improvements across the organization. With opportunities for career advancement and a comprehensive benefits package, this position is ideal for someone looking to make a significant impact in clinical research while enjoying the flexibility of remote work. Join a forward-thinking organization committed to excellence and innovation in healthcare.

Benefits

Comprehensive benefits package

Paid time off

401(k)

Remote work opportunity

Qualifications

• 6+ years of experience in clinical research with a focus on data standards.
• Experience leading development for data collection and reporting standards.

Responsibilities

• Participate in defining standards for data collection and review rules.
• Create and review SDTM Mapping Specifications for regulatory submissions.

Skills

SDTM Mapping

Data Collection

Clinical Research

Regulatory Submissions

Education

Master's Degree in Science

Bachelor's Degree in Science

Job description

Employer Industry: Pharmaceutical and Biotechnology

Why Consider this Job Opportunity:
- Opportunity for career advancement and growth within the organization
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Eligible to participate in short-term incentive programs
- Remote work opportunity, allowing flexibility in your work environment
- Engage in meaningful work that contributes to innovative medicines and solutions for serious health issues

What to Expect (Job Responsibilities):
- Actively participate with a cross-functional team to define standards such as SDTM mapping, data collection, and data review rules
- Ensure consistency across various standard types and educate the organization on their proper use
- Create, review, and provide feedback on SDTM Mapping Specifications and Trial Design Domains
- Oversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for regulatory submissions
- Stay current with industry standards, identify improvements to processes, and drive those improvements to completion

What is Required (Qualifications):
- Experience leading development of standards for data collection, tabulation, analysis, or reporting
- Experience with SDTM and CDASH
- MS with 6 years or BS with 8 years of relevant clinical research experience
- Experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
- Active participation in CDISC teams preferred

How to Stand Out (Preferred Qualifications):
- Experience with standards related to eye care, neuroscience, or medical aesthetics
- Experience with standards related to devices
- Experience with ADaM, Analysis Results Metadata, or TLF standards

#Pharmaceutical #ClinicalResearch #RemoteWork #CareerGrowth #DataStandards

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