Senior Statistical Analyst

BioSpace; Branchburg Township (NJ); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Senior Statistical Analyst to play a vital role in the research and development of new products. The position involves analyzing clinical trial data, leading programming activities, and interfacing with various departments. Candidates should possess a strong background in SAS programming and drug development processes, with opportunities for remote work across the US.

Qualifications

• 6+ years of relevant experience for MS or 8+ years for BS.
• Deep understanding of SAS programming related to drug development.
• Fundamental knowledge of CDISC Standards.

Responsibilities

• Leads statistical programming activities for projects with lower complexity.
• Develops SAS programs for creating ADaM data sets following CDISC standards.
• Prepares documentation for regulatory filings.

Skills

SAS programming

Communication skills

Drug development knowledge

Education

MS in Statistics, Computer Science, or related field

BS in Statistics, Computer Science, or related field

Job description

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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: immunology, oncology, neuroscience, and eye care, along with products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Senior Statistical Analyst/Statistical Analyst plays a key role in the research and development of new pharmaceutical products. Responsibilities include analyzing and reporting clinical trial data, leading statistical programming activities for clinical studies and projects with lower complexity. The role involves interfacing with Statistics, Data Sciences, Medical Writing, Regulatory Publishing, and Clinical Operations.

1. Leads statistical programming activities for projects with lower complexity.
2. Leads statistical programming activities for studies.
3. Develops SAS programs for creating ADaM data sets following CDISC standards.
4. Develops SAS programs for creating Tables, Listings, and Figures.
5. Validates ADaM data sets, Tables, Listings, and Figures.
6. Creates specifications for ADaM data set structures for studies and integrated data.
7. Prepares documentation for regulatory filings, including reviewer guides and data definition documents.
8. Leads the development of standard SAS Macros and contributes to SOP development.
9. Provides oversight and mentorship to Statistical Programmers and Analysts.

Qualifications

Senior Statistical Analyst

• MS in Statistics, Computer Science, or related field with 6+ years of relevant experience, or BS with 8+ years.
• Deep understanding of SAS programming related to drug development.
• Fundamental knowledge of CDISC Standards.
• Understanding of the drug development process, including regulatory filings.
• Strong communication skills, both oral and written.
• Ability to estimate effort for programming activities accurately.

Statistical Analyst

• MS in Statistics, Computer Science, or related field with 3+ years of relevant experience, or BS with 5+ years.
• Practical understanding of SAS programming concepts related to drug development.
• Basic knowledge of CDISC Standards.
• Understanding of the drug development process.
• Excellent communication skills.

This is a remote opportunity, and hiring can occur anywhere in the US.